Associate Regulatory Affairs Coordinator

Role Purpose & Context

Role Summary

The Associate Regulatory Affairs Coordinator is here to make sure our regulatory submissions—that's all the paperwork we send to Health Authorities to get our products approved—are put together accurately and on time. Day-to-day, you'll be gathering documents, entering data into our systems, and checking things against checklists. You're essentially the first line of defence, ensuring the administrative side of things is flawless so the more senior folks can focus on the tricky scientific bits. When you do this job well, submissions go out without a hitch, avoiding costly delays and frustrating 'Refuse to File' decisions. If things go wrong, even a tiny error can mean weeks or months of delays, costing the company a lot of money and, more importantly, slowing down access to vital products for patients. The biggest challenge? It's often about chasing busy people for documents and making sure every single detail is perfect, even when you're under pressure. The reward, though, is knowing you're a fundamental part of getting important products to market.

Reporting Structure

• Reports to: Regulatory Affairs Coordinator
• Direct reports: None, you'll be learning the ropes and supporting the team.
• Matrix relationships: Junior Regulatory Affairs Assistant, Regulatory Affairs Administrator, Compliance Documentation Assistant,

Key Stakeholders

Internal:

• Your direct manager (Regulatory Affairs Coordinator/Senior Coordinator)
• Senior Regulatory Affairs Specialists (for task guidance)
• Quality Assurance team (for document control and process adherence)
• R&D scientists (you'll be asking them for source documents)
• Project Managers (they'll want updates on submission progress)

External:

• External vendors (sometimes you'll help coordinate document requests)
• Health Authorities (indirectly, as your work contributes to what they receive)

Organisational Impact

Scope: Your work directly supports the timely and accurate submission of regulatory dossiers. Get it right, and we keep things moving. Get it wrong, and we could face significant delays in getting products approved, which impacts revenue and, more importantly, patient access. You're building the foundation for our compliance.

Performance Metrics

Quantitative Metrics

1. Metric: Submission Data Entry Accuracy
2. Desc: The percentage of data points you enter into our Regulatory Information Management (RIM) system that are correct and match the source documents.
3. Target: Target: 99.5% accuracy (meaning very few errors)
4. Freq: Measured: Monthly spot checks and during submission reviews
5. Example: Example: If you enter 200 data points for a submission, we'd expect no more than 1 error. Catching a typo in a product name or a wrong date before it goes out is a win.
6. Metric: On-Time Document Gathering
7. Desc: How often you get the required documents from internal teams by the agreed deadline, especially when supporting a submission.
8. Target: Target: 95% of assigned document requests completed on time
9. Freq: Measured: Weekly against your task list and project plans
10. Example: Example: If you're asked to collect 10 documents for a submission by Friday, getting 9 of them in by then, despite chasing, is good. Getting all 10 is excellent.
11. Metric: Administrative eCTD Validation Errors
12. Desc: The number of basic administrative errors (like incorrect file naming or missing metadata) in the sections of eCTD dossiers you've helped to prepare or publish.
13. Target: Target: Less than 1% of documents show administrative errors
14. Freq: Measured: Per submission, during publishing validation checks
15. Example: Example: You've helped prepare 100 documents for a module, and only one had a wrong bookmark. That's what we're aiming for. Zero is always the goal, of course!
16. Metric: Commitment Tracking Update Timeliness
17. Desc: How quickly you update the system when a regulatory commitment (a promise we've made to a Health Authority) is completed or changes status.
18. Target: Target: All updates within 24 hours of receiving information
19. Freq: Measured: Weekly review of commitment tracker entries
20. Example: Example: R&D tells you a study promised to the FDA is finished. You update the tracker the same day. This helps us stay on top of our obligations.

Qualitative Metrics

1. Metric: Adherence to Standard Operating Procedures (SOPs)
2. Desc: How consistently you follow our established processes and guidelines for document management, data entry, and submission preparation.
3. Evidence: Evidence: Your manager rarely needs to correct your process steps. You can explain the 'why' behind a procedure. You ask clarifying questions when a process isn't clear, rather than guessing.
4. Metric: Learning and Application of Regulatory Knowledge
5. Desc: Your proactive effort to learn about regulatory requirements and systems, and how well you apply that new knowledge to your daily tasks.
6. Evidence: Evidence: You're asking thoughtful questions about 'why' we do things a certain way, not just 'how'. You pick up new system functionalities quickly. You can explain basic CTD structure after a few months.
7. Metric: Proactive Problem Identification
8. Desc: Your ability to spot potential issues or discrepancies in documents or data before they become bigger problems, and then escalate them appropriately.
9. Evidence: Evidence: You flag a document that looks like an old version. You notice a date mismatch between two records. You don't just ignore something that 'feels' wrong, you bring it up.
10. Metric: Team Collaboration and Support
11. Desc: How well you work with your immediate team, offering support when needed and responding positively to feedback and requests.
12. Evidence: Evidence: You're quick to offer help if a colleague is swamped. You take feedback constructively. You communicate clearly about your progress and any blockers you hit.

Primary Traits

• Trait: Meticulously Organised
• Manifestation: You're the sort of person who colour-codes their notes, always knows where that one specific file is, and can't stand a messy desktop. You'll keep flawless version control on documents (e.g., 'Doc_v0.1_draft', 'Doc_v1.0_final') without even thinking about it. You'll manage a complex tracker of deadlines for multiple tasks simultaneously without missing a beat. Honestly, you can probably instantly locate a specific supporting document from a submission made last week, or even last year, because you know exactly how things are filed.
• Benefit: In regulatory affairs, a single wrong document submitted in a huge dossier can lead to a 'Refuse-to-File' (RTF) decision. That means millions of pounds lost and patients waiting months or even years longer for a product. Your ability to keep everything perfectly in its place is literally what prevents these catastrophic errors. It's not just about neatness; it's about preventing massive business and patient impact.
• Trait: Process-Driven
• Manifestation: You thrive on clear instructions and checklists. When there's a process, you follow it to the letter, even if someone suggests a 'shortcut'. You'll naturally create your own mini-checklists for routine tasks. You understand that documenting every key communication and decision in the official record isn't optional, it's just how we do things. You're not someone who tries to 'freelance' or gets creative with established procedures.
• Benefit: Regulatory affairs is a zero-error game built entirely on auditable processes. Every step we take needs to be defensible during an inspection. If you go off-script, you introduce unacceptable compliance risks that will absolutely be discovered by an auditor. We need people who understand that sticking to the process isn't bureaucracy; it's our defence against serious regulatory findings.
• Trait: Calm Under Pressure
• Manifestation: Imagine this: a senior colleague needs a critical document for a submission in 24 hours, and the person who has it is on holiday. You don't panic. You methodically figure out who else might have it, send polite but firm emails, and coordinate with other teams. You handle last-minute document changes or urgent requests from R&D without getting flustered or emotional. You just get on with it.
• Benefit: Our environment is often defined by immovable external deadlines set by Health Authorities. When a 'clock-stop' happens, or a submission deadline looms, things can get incredibly tense. Panic leads to mistakes, and mistakes here are expensive. Your ability to remain focused and methodical, even when the clock is ticking loudly, is absolutely critical to our success and to keeping our products moving through the approval pipeline.

Supporting Traits

• Trait: Diplomatic & Tenacious
• Desc: At this level, it means politely but persistently chasing colleagues for documents they've forgotten to send you. You'll need to follow up without being annoying, but also without giving up until you get what you need. It's a fine line, but essential.
• Trait: Inquisitive
• Desc: You're someone who asks 'why' to understand the underlying purpose of a task, not just 'how' to do it. This helps you learn faster and spot potential issues. You're not afraid to ask clarifying questions if something doesn't make sense.
• Trait: Resilient
• Desc: You'll get feedback, sometimes direct, and sometimes you'll be told a document isn't quite right. You're able to take that on the chin, learn from it, and come back stronger, seeing it as part of the learning process rather than a personal failure.

Primary Motivators

1. Motivator: Making a Tangible Contribution
2. Daily: You'll feel good knowing that your accurate data entry and organised documents are directly contributing to getting a product approved. You're not just pushing paper; you're enabling patient access.
3. Motivator: Learning and Development
4. Daily: You're keen to understand the complex world of regulatory affairs. You'll enjoy picking up new system skills, learning about different regulations, and seeing how your small tasks fit into the bigger picture.
5. Motivator: Working in a Structured Environment
6. Daily: You thrive on clear processes, checklists, and defined ways of working. You appreciate knowing exactly what's expected of you and how to achieve it, rather than having to figure it all out from scratch.

Potential Demotivators

Honestly, this role isn't for everyone. You'll spend a fair bit of your time chasing busy senior scientists for documents they see as 'admin'. You'll often be asked to do repetitive tasks, like checking hundreds of hyperlinks or ensuring every single document has the right version number. The 'urgent' request that disrupted your Thursday might get deprioritised on Friday because something else blew up. You'll learn a lot, but you won't be making big strategic decisions for a while. If you need constant novelty, hate following strict rules, or get easily frustrated by chasing people, you'll probably struggle here.

Common Frustrations

1. The 'SME Chase': Spending a good chunk of your day before a deadline trying to get critical input from people who are swamped and see your request as low priority.
2. Repetitive Tasks: A lot of the work involves meticulous checking, data entry, and following rigid formats. It's essential, but not always exciting.
3. Lack of Immediate Impact: You're contributing, but you won't see your work directly influence major strategic decisions for a while.
4. The 'Hurry Up and Wait' Cycle: Frantic periods of work to meet a deadline, followed by long stretches of waiting for agency feedback, which can make workflow planning a bit odd.

What Role Doesn't Offer

1. High-level strategic decision-making from day one.
2. A fast-track to management (you'll need to master the basics first).
3. Lots of external client-facing interaction or travel.
4. A 'move fast and break things' culture; here, we move carefully and fix things before they break.

ADHD Positives

1. The clear, structured tasks and checklists can provide a helpful framework, reducing the mental load of 'what to do next'.
2. The frequent need to switch between different documents and systems for various tasks might suit those who enjoy task variety.
3. The 'urgent' nature of some regulatory deadlines can provide a helpful burst of focus and hyper-attention when needed.

ADHD Challenges and Accommodations

1. **Challenge:** Repetitive data entry or document checking can be difficult to sustain focus on for long periods.
2. **Accommodation:** We can explore breaking down larger tasks into smaller, time-boxed chunks, using tools for focus (e.g., Pomodoro timers), and varying task types throughout the day.
3. **Challenge:** The need for meticulous detail and zero errors can be anxiety-inducing.
4. **Accommodation:** We'll provide robust checklists and peer review processes to act as safety nets, and focus on learning from errors rather than punitive measures.

Dyslexia Positives

1. The emphasis on visual organisation (e.g., clear folder structures, colour-coding) can be beneficial.
2. The use of structured templates for documents and data entry can reduce the need for free-form writing.
3. Strong verbal communication skills, often found in dyslexic individuals, are valuable for clarifying requirements and chasing information.

Dyslexia Challenges and Accommodations

1. **Challenge:** The high volume of reading and meticulous proofreading required for regulatory documents can be demanding.
2. **Accommodation:** We can provide access to text-to-speech software, screen readers, and encourage proofreading by colleagues. We'll also ensure documents are formatted with clear fonts and good spacing.
3. **Challenge:** Strict adherence to grammar and spelling in official submissions is non-negotiable.
4. **Accommodation:** We'll use advanced grammar checkers, provide templates with pre-approved phrasing, and ensure all critical documents undergo thorough review by multiple team members.

Autism Positives

1. The highly structured nature of regulatory processes, with clear rules and procedures, can be a comfortable fit.
2. The focus on factual accuracy, data integrity, and logical adherence to guidelines aligns well with analytical thinking.
3. Predictable daily routines and a clear understanding of expectations can reduce anxiety.

Autism Challenges and Accommodations

1. **Challenge:** The need for frequent, sometimes persistent, communication with various internal stakeholders to chase documents.
2. **Accommodation:** We can provide clear communication templates and scripts for common requests. We'll also support you in finding the most effective communication channels (email, chat, brief call) for different situations.
3. **Challenge:** Unexpected changes in priorities or urgent requests can be disruptive.
4. **Accommodation:** We aim to minimise last-minute changes, but when they occur, we'll provide clear context and support to help you re-prioritise. We'll also give you tools to manage your workload effectively.

Key Responsibilities

Experience Levels Responsibilities

1. Level: Entry Level (0-2 years)
2. Responsibilities: Assist in compiling regulatory submission documents by gathering, formatting, and organising various reports and certificates from internal departments, making sure they're ready for review.
3. Perform accurate data entry into our Veeva Vault RIM system, updating product registrations, submission statuses, and commitment trackers, ensuring every detail is correct.
4. Support the creation of basic eCTD (electronic Common Technical Document) modules, which means putting documents into the right folders and checking hyperlinks under close supervision.
5. Maintain and archive regulatory documentation, ensuring all records are filed correctly, easily retrievable, and adhere to our Good Documentation Practices (GDP) standards.
6. Conduct initial quality checks on documents for completeness, correct version control, and adherence to templates before they're passed to a senior colleague for review.
7. Learn and apply our internal Standard Operating Procedures (SOPs) for regulatory processes, asking questions when things aren't clear, and always following the established steps.
8. Help manage regulatory commitments by tracking deadlines and following up with internal teams to ensure promised actions to Health Authorities are met on time.
9. Supervision: You'll receive daily check-ins from your manager or a senior colleague. All your work, especially data entry and document compilation, will be reviewed before it's finalised or submitted. Think of it as paired work initially, with increasing independence as you learn.
10. Decision: You won't be making independent regulatory decisions. Any questions about interpretation of regulations, changes to processes, or complex document issues must be escalated to your direct manager or a senior team member. Your role is to execute tasks precisely as instructed.
11. Success: Success here means consistently delivering accurate work, meeting your assigned deadlines, and showing a proactive attitude towards learning. It's about being reliable and asking smart questions when you're unsure, rather than making assumptions.

Decision-Making Authority

• Type: Document Version Control
• Entry: Follow established naming conventions and versioning rules precisely. Escalate if you're unsure which version to use.
• Mid: Independently manage version control for your assigned documents. Propose minor improvements to naming conventions.
• Senior: Define and implement version control strategies for complex dossiers. Train junior staff on best practices.
• Type: Data Entry for Submissions
• Entry: Perform data entry as instructed, ensuring 99.5%+ accuracy. Escalate any discrepancies immediately.
• Mid: Independently enter and validate submission data. Troubleshoot minor data entry issues.
• Senior: Oversee data entry quality across a submission portfolio. Advise on RIM system improvements for data integrity.
• Type: Health Authority Query Response Strategy
• Entry: No involvement in strategy. You might help gather supporting documents for a response under direct guidance.
• Mid: Help draft sections of responses based on provided input. Identify and flag potential inconsistencies.
• Senior: Lead the coordination of responses to routine queries. Propose initial response strategies for minor queries.
• Type: Process Deviations
• Entry: Report any observed or potential deviations from SOPs immediately to your manager. Do not attempt to resolve independently.
• Mid: Identify minor process deviations and propose corrective actions within your scope. Escalate significant deviations.
• Senior: Investigate and document significant process deviations. Implement corrective and preventative actions (CAPAs) for process improvements.

Competency Requirements

Foundation Skills (Transferable)

These are the fundamental skills that underpin everything you'll do. We're looking for someone who's naturally organised, can communicate clearly, and is keen to learn how to solve problems within a structured environment. These aren't just 'nice-to-haves'; they're essential for getting the job done right.

• Category: Communication & Collaboration
• Skills: Clear Written Communication: You can write concise emails and document notes that are easy to understand, even when explaining technical details. No jargon, just clarity.
• Active Listening: You pay attention to instructions, ask clarifying questions, and make sure you've understood what's being asked before you dive in.
• Teamwork: You work well with others, offering help when you can and asking for it when you need it. You understand that we're all in this together.
• Category: Problem-Solving & Adaptability
• Skills: Issue Identification: You can spot when something doesn't look right in a document or a process, even if you don't know the solution. You'll flag it, not ignore it.
• Following Instructions: You're great at taking detailed instructions and executing them precisely, without cutting corners or making assumptions.
• Learning Agility: The regulatory landscape changes, and so do our internal processes. You're keen to learn new things and adapt to new ways of working.
• Category: Organisation & Attention to Detail
• Skills: Meticulous Organisation: You keep your files, emails, and tasks perfectly organised. You know where everything is, and you can retrieve it quickly.
• Accuracy Focus: You have a natural eye for detail, spotting typos, incorrect dates, or misaligned formatting. You double-check your work instinctively.
• Time Management: You can manage multiple small tasks, prioritise them based on deadlines, and get things done on time, even when you're chasing others.

Functional Skills (Role-Specific Technical)

These are the specific skills and tools you'll be using day-to-day. We don't expect you to be an expert from day one, but a willingness to learn and a basic understanding of some of these areas will really help you hit the ground running.

Technical Competencies

• Skill: Good Documentation Practices (GDP)
• Desc: You understand the core principles of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) and why they're critical for every document we handle. You know how to apply these rules when preparing, reviewing, or archiving documents.
• Level: Intermediate
• Skill: Common Technical Document (CTD) Structure
• Desc: You have a basic grasp of what the CTD is and its five main modules. You understand that documents need to go into specific sections and why that structure matters for Health Authorities.
• Level: Basic
• Skill: Regulatory Pathway Concepts (Basic)
• Desc: You'll learn the difference between, say, an initial marketing authorisation and a post-approval change. You won't be determining pathways, but you'll understand the basic terminology.
• Level: Basic
• Skill: Health Authority Query Management (Support)
• Desc: You understand what a 'Health Authority Query' (RFI) is and why quick, accurate responses are critical. You'll learn how to help gather information for these responses under guidance.
• Level: Basic

Digital Tools

• Tool: Veeva Vault RIM
• Level: Intermediate
• Usage: You'll use this daily to locate documents, complete data entry for submissions (like product registrations), track commitments, and run pre-configured reports. You'll understand the basic object model and how to navigate the system.
• Tool: Lorenz docuBridge / Extedo eCTDmanager
• Level: Basic
• Usage: Under supervision, you'll learn to import documents, set basic properties, and perform simple publishing tasks for a single region. This is about learning the mechanics of eCTD publishing.
• Tool: TrackWise Digital / MasterControl QMS
• Level: Intermediate
• Usage: You'll initiate and process records for Change Controls, Deviations, and CAPAs. You'll also pull documentation from the QMS to support regulatory filings, understanding where to find the right quality records.
• Tool: SharePoint (with controlled workflows)
• Level: Intermediate
• Usage: You'll check documents in/out, follow strict version control protocols (e.g., v0.1, v1.0), and navigate complex site structures to find source documents. It's our central hub for many controlled documents.
• Tool: Cortellis / Tarius Regulatory Intelligence
• Level: Basic
• Usage: You'll execute simple searches for specific guidance documents or competitor approvals when given clear instructions. This helps you start to understand the regulatory landscape.
• Tool: MS Excel (Intermediate)
• Level: Intermediate
• Usage: You'll use functions like VLOOKUP/XLOOKUP to cross-reference submission tracking sheets, create pivot tables for status summaries, and maintain version control on various trackers. It's your go-to for organising data.

Industry Knowledge

• Area: Pharmaceutical/Medical Device Industry Basics
• Desc: A foundational understanding of how pharmaceutical or medical device products are developed, manufactured, and brought to market. You don't need to be a scientist, but knowing the basics helps you understand the documents you're handling.
• Area: Regulatory Compliance Principles
• Desc: An appreciation for why regulations exist, the importance of compliance, and the potential consequences of non-compliance (e.g., fines, product recalls, delays).

Regulatory Compliance Regulations

• Reg: EU Good Documentation Practices (GDP)
• Usage: You'll apply GDP principles to all document handling, ensuring documents are attributable, legible, contemporaneous, original, and accurate (ALCOA+). This is non-negotiable.
• Reg: ICH Guidelines (e.g., ICH M4 - CTD)
• Usage: You'll learn about the International Council for Harmonisation (ICH) guidelines, particularly M4 on the CTD structure, as you prepare submission components.
• Reg: FDA 21 CFR Part 11 (Electronic Records)
• Usage: You'll understand the basics of electronic records and electronic signatures, especially as they apply to our RIM and QMS systems, ensuring compliance with data integrity rules.

Essential Prerequisites

• A keen eye for detail – you spot the tiny errors others miss.
• Exceptional organisational skills – you can manage multiple tasks and deadlines without dropping the ball.
• Strong written and verbal communication skills – you can clearly convey information and ask questions.
• Proficiency with standard office software (MS Office Suite, especially Word and Excel).
• A genuine interest in learning about regulatory affairs and the pharmaceutical/medical device industry.
• The ability to work effectively in a team, taking direction and offering support.

Career Pathway Context

These aren't just a list of things we'd like to see; these are the foundational building blocks for a successful career in regulatory affairs. If you've got these sorted, you're in a great position to learn and grow with us. We'll teach you the specifics, but these core skills are what you'll bring to the table.

Qualifications & Credentials

Emerging Foundation Skills

• Skill: AI-Assisted Document Validation
• Why: Manual document checks for compliance with templates, formatting, and cross-referencing are incredibly time-consuming and prone to human error. AI tools are getting good at automating these initial validation steps.
• Concepts: [{'concept_name': 'Natural Language Processing (NLP)', 'description': "Understanding how AI can 'read' and interpret text to check for specific keywords, phrases, or formatting rules."}, {'concept_name': 'Pattern Recognition', 'description': 'How AI identifies deviations from established document templates or naming conventions.'}, {'concept_name': 'Automated Cross-Referencing', 'description': 'Tools that can verify if all references within a document link to actual, existing files.'}]
• Prepare: This month: Start using advanced grammar and style checkers (like Grammarly Premium) for all your written work, even internal emails.
• Next quarter: Explore how our existing document management systems (like Veeva) offer any automated validation features.
• Within 6 months: Participate in any pilot programmes for new AI document validation tools, providing feedback on their effectiveness.
• Throughout: Always manually validate AI outputs—the human eye is still the final arbiter.
• QuickWin: Start using AI tools (like ChatGPT or Bard) to summarise complex internal documents or draft initial email responses, then meticulously check and refine their output. It's a great way to learn their strengths and weaknesses.

Advancing Technical Skills

• Skill: Advanced RIM System Querying & Reporting
• Why: As you gain experience, you won't just be entering data; you'll need to extract meaningful insights. Being able to build custom reports helps us track our submission portfolio and identify bottlenecks.
• Concepts: [{'concept_name': 'Boolean Logic in Search', 'description': 'Using AND, OR, NOT to refine your searches for specific data points within Veeva Vault RIM.'}, {'concept_name': 'Custom Report Building', 'description': 'Learning to create reports that pull specific data fields to answer business questions, rather than just using pre-configured ones.'}, {'concept_name': 'Dashboard Configuration', 'description': 'Understanding how to set up visual dashboards in RIM to track key metrics like submission status or commitment deadlines.'}]
• Prepare: This quarter: Ask your manager for training on advanced search functions within Veeva Vault RIM.
• Next 6 months: Shadow a senior colleague who builds custom reports, asking them to explain their logic.
• Within 12 months: Take an online course or internal training on advanced reporting features of our RIM system.
• Throughout: Practice building simple reports for your own tracking needs, even if they're just for personal use.
• QuickWin: Experiment with different search filters and operators in Veeva Vault RIM to find documents or records more efficiently. See if you can find a piece of information faster than your colleague.
• Skill: eCTD Publishing Fundamentals
• Why: While you'll start with basic support, understanding the 'how' of eCTD publishing is crucial for progression. This involves knowing the technical requirements that turn a collection of documents into a valid submission package.
• Concepts: [{'concept_name': 'XML Backbone', 'description': 'The underlying technical structure that organises the eCTD modules and documents.'}, {'concept_name': 'Hyperlinking & Bookmarking', 'description': 'The critical process of creating navigation links within the dossier for easy review by Health Authorities.'}, {'concept_name': 'Validation Criteria', 'description': 'The technical rules (e.g., file size limits, PDF properties) that an eCTD must meet to be accepted by an agency.'}]
• Prepare: This quarter: Ask to sit in on a publishing session with a senior colleague to see the process in action.
• Next 6 months: Complete any internal training modules on eCTD publishing basics.
• Within 12 months: Take on small, clearly defined publishing tasks (e.g., preparing a single module) under direct supervision.
• Throughout: Review published dossiers to understand how they are structured and navigated.
• QuickWin: Familiarise yourself with the eCTD guidance documents available publicly (e.g., EMA, FDA) to understand the structure and technical requirements, even if you're not publishing yet.

Education Requirements

• Level: Minimum
• Req: A-Levels (or equivalent) in relevant subjects (e.g., Science, English, Business).
• Alts: Alternatively, demonstrable experience in a highly administrative, detail-oriented role within a regulated environment (e.g., Quality Assurance, Document Control) can be considered.
• Level: Preferred
• Req: A Bachelor's degree (or equivalent) in a life science, pharmacy, chemistry, or a related scientific discipline.
• Alts: A degree isn't strictly necessary if you have the right attitude and a track record of meticulous work, but it certainly helps with understanding the context of the documents you'll handle.

Experience Requirements

We're looking for 0-2 years of experience. This could be a recent graduate, someone with administrative experience in a regulated industry, or even a highly organised individual with a keen interest in compliance. What truly matters is your ability to follow processes, pay close attention to detail, and a genuine desire to learn the ins and outs of regulatory affairs. Experience in document management, data entry, or quality assurance within a pharmaceutical, medical device, or other highly regulated sector would be a real bonus.

Preferred Certifications

• Cert: Regulatory Affairs Certificate (RAC) - Entry Level
• Prod: RAPS (Regulatory Affairs Professionals Society)
• Usage: Shows a foundational understanding of global regulatory requirements and processes. Something you might consider pursuing once you've gained some experience with us.
• Cert: Good Documentation Practices (GDP) Training
• Prod: Various accredited providers
• Usage: Demonstrates a solid understanding of the principles of creating and maintaining accurate, compliant records, which is essential for this role.

Recommended Activities

• Attend internal training sessions on our regulatory systems (Veeva, eCTD tools).
• Participate in webinars or online courses about specific regulations (e.g., EU MDR, FDA guidance).
• Join industry associations like RAPS (Regulatory Affairs Professionals Society) for networking and learning.
• Read industry publications and regulatory intelligence newsletters to stay informed (we'll point you to the good ones).

Career Progression Pathways

Entry Paths to This Role

• Path: Recent Graduate (Life Sciences/Admin)
• Time: 0-1 year
• Path: Administrative Assistant (Regulated Industry)
• Time: 1-2 years
• Path: Quality Assurance Assistant/Technician
• Time: 1-2 years

Career Progression From This Role

• Pathway: Regulatory Affairs Coordinator (Level 2)
• Time: 2-3 years in the Associate role

Long Term Vision Potential Roles

• Title: Senior Regulatory Affairs Specialist (IC Path)
• Time: 5-8 years from Associate
• Title: Regulatory Affairs Manager (Management Path)
• Time: 8-12 years from Associate
• Title: Director, International Regulatory Affairs
• Time: 12-16 years from Associate

How Zavmo Delivers This Role's Development

DISCOVER Phase: Skills Gap Analysis

Zavmo maps your current competencies against all requirements in this job description through conversational assessment. We evaluate your foundation skills (communication, strategic thinking), functional skills (CRM expertise, negotiation), and readiness for career progression.

Output: Personalised skills gap heat map showing strengths and priorities, estimated time to competency, neurodiversity accommodations.

DISCUSS Phase: Personalised Learning Pathway

Based on your DISCOVER results, Zavmo creates a personalised learning plan prioritised by impact: foundation skills first, then functional skills. We adapt to your learning style, pace, and neurodiversity needs (ADHD, dyslexia, autism).

Output: Week-by-week schedule, each module linked to specific job responsibilities, checkpoints and milestones.

DELIVER Phase: Conversational Learning

Learn through conversation, not boring modules. Zavmo uses 10 conversation types (Socratic dialogue, role-play, coaching, case studies) to build competence. Practice difficult QBR presentations, negotiate tough renewals, and handle churn conversations in a safe AI environment before facing real clients.

Example: "For 'Stakeholder Mapping', Zavmo will guide you through analysing a complex enterprise account, identifying key decision-makers, and building an engagement strategy."

DEMONSTRATE Phase: Competency Assessment

Zavmo automatically builds your evidence portfolio as you learn. Every conversation, practice scenario, and application example is captured and mapped to NOS performance criteria. When ready, your portfolio supports OFQUAL qualification claims and demonstrates competence to employers.

Output: Competency matrix, evidence portfolio (downloadable), qualification readiness, career progression score.