UK

United Kingdom · Compliance, quality and safety · Director/VP (16-20 years)

Director of Quality & Regulatory Affairs

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  • Experience bandDirector/VP (16-20 years)
  • Direct reports25-100+ reports
  • Reports toChief Quality Officer (CQO) or Business Unit Managing Director
  • UK framework levelUsually a director, accountable for a division and its numbers

Also advertised as Head of Quality & Compliance (Business Unit) · VP, Quality Assurance (Regional) · Senior Director, Governance, Risk & Compliance

Built on 43,079 real UK job descriptions we analysed · grounded in qualifications employers recognise

Two short quizzes about you

1From this job to a course

The qualifications matched to this job

GQA Level 5 Diploma in the Practice of Process Safety Management GQA Qualifications Limited · Level 5 · covers 4 of 15 standards
IAO Level 5 Diploma in Leadership and Management Innovate Awarding · Level 5 · covers 1 of 15 standards
CICM Level 5 Diploma in Credit and Collections Management Chartered Institute of Credit Management · Level 5 · covers 1 of 15 standards
FDQ Level 3 Certificate for Proficiency in Food Manufacturing Excellence FDQ Limited · Level 3 · covers 3 of 15 standards
FDQ Level 3 Diploma for Proficiency in Food Manufacturing Excellence FDQ Limited · Level 3 · covers 1 of 15 standards

Matched from the standards this job is measured against: a suggestion, not an official ruling.

The units you would start with

Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety GQA Level 5 Diploma in the Practice of Process Safety Management
Managing quality and quality systems IAO Level 5 Diploma in Leadership and Management
Compliance with legal, regulatory, ethical and social requirements CICM Level 5 Diploma in Credit and Collections Management
Manage compliance to support achieving excellence in food operations FDQ Level 3 Certificate for Proficiency in Food Manufacturing Excellence
Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards Level 3 Technical Occupational Entry in the Principles and Practice for Pharmacy Technicians (Diploma)

The future skills this job leans on

AI Fluency working with AI as a thinking partner
Data Fluency turning numbers into a decision
AI Governance Fluency using AI responsibly
Automation Fluency building AI into how work runs
Sustainability Fluency building care for people and planet into the work
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Your Plan Illustration

Built for Director of Quality & Regulatory Affairs

5 units that map to this job, from the qualifications that cover it.

  1. Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety GQA Qualifications Limited · covers 4 of 15 standards Level 5
  2. Managing quality and quality systems Innovate Awarding · covers 1 of 15 standards Level 5
  3. Compliance with legal, regulatory, ethical and social requirements Chartered Institute of Credit Management · covers 1 of 15 standards Level 5
  4. Manage compliance to support achieving excellence in food operations FDQ Limited · covers 3 of 15 standards Level 3
  5. Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards · covers 3 of 15 standards Level 3
These are the real units behind this job, in the order they rank for it. Nothing here is marked done, because this plan has not been started by anyone yet. Yours would fill in as you go.

2AI and this work

Will AI change your work as a Director of Quality & Regulatory Affairs?

Nobody can say exactly how. Here is what this job is being asked for next, and where to start.

The new skills this role is being asked for

  • AI & Automation Strategy for Compliance
  • ESG (Environmental, Social, Governance) Integration
Why each one is rising

The future skills this job leans on

We'll only ever tell you what we can actually back up. No hype, no scare tactics.

What happens when you start

Next, a free account. We build your Director of Quality & Regulatory Affairs plan as you set up, starting with a Future Fluency module on using AI in your job. No card.

Your first Future Fluency module is free. After that, your AI tutor is £70 a month.

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3What this role really is

A Director of Quality & Regulatory Affairs leads quality and regulatory risk management across a business unit or region.

4What you'd actually use

The tools this job runs on, and how well you'd need to know each one.

QMS (MasterControl, Veeva QualityDocs, TrackWise Digital) Strategic

Leads platform selection, defines enterprise integration strategy (QMS-ERP), owns the technology roadmap for quality systems across the business unit, uses executive dashboards to monitor performance.

EHS & Safety Platform (Intelex, Cority, Enablon) Strategic

Uses executive dashboards to monitor enterprise-wide safety metrics (LTIFR, TRIR), presents safety performance to the board, defines strategic requirements for platform enhancements.

Analytics & BI Platform (Tableau, Power BI) Advanced

Defines the key enterprise quality and safety metrics and dashboard requirements for C-suite and board-level reporting. Interprets complex data trends to inform strategic decisions and risk mitigation plans.

GRC & Risk Platform (ServiceNow GRC, LogicGate, Archer) Strategic

Oversees the enterprise risk management framework for the business unit, uses GRC data to inform strategic decisions and board reporting, defines integration points with other systems.

Board Reporting Tools (Diligent Boards, Nasdaq Boardvantage) Advanced

Presents the quarterly Quality & Safety report to the Board of Directors using the platform, ensuring clear, concise, and impactful communication of critical information.

5What you get to decide, and how that grows

Power in a job isn't your title. It's what you're allowed to decide. Here's how it grows as you move up.

The choiceComing in Where you are nowThe step above
Strategic Quality Programme Investment Escalate recommendation to manager. Propose and justify to department head, seek approval. Lead business case development, present to business unit leadership for approval.
Regulatory Submission Approval Prepare draft, seek manager review and approval. Draft and review, submit for senior manager approval. Lead preparation, sign off on technical content, submit for Director approval.
Product Release/Hold Decision Escalate non-conformance for review. Assess impact of non-conformance, recommend disposition to manager. Lead investigation, make final technical disposition recommendation, consult with Director.
Team Hiring & Structure No hiring authority. Participate in interviews, provide input on candidates. Interview and recommend candidates, manage onboarding for junior staff.

6How you'll be judged

The scoreboard, and what is not on it. The hard targets, how often each is actually looked at, and the quiet signals that never reach a dashboard.

Cost of Poor Quality (COPQ) Reduction
The total cost associated with defects, rework, warranty claims, and regulatory fines within your business unit.
Target · Reduce COPQ by 15-20% year-on-year.

If your business unit's COPQ was £5M last year, you'd aim for £4M-£4.25M this year by fixing systemic issues and improving processes.

Regulatory Audit Findings
The number and severity of findings (major, minor, observations) from external regulatory inspections and audits.
Target · Achieve zero critical or major findings in any regulatory audit.

Successfully navigate an MHRA inspection for a new product line with only 2-3 minor observations, all closed out within 30 days.

Lost Time Injury Frequency Rate (LTIFR)
The rate of workplace injuries resulting in lost time from work within your business unit.
Target · Reduce LTIFR by 10% year-on-year, aiming for top-quartile industry performance.

If your LTIFR was 0.8 last year, you'd aim for 0.72 this year, showing tangible improvements in safety programmes.

Product Recall/Field Action Rate
The frequency and scale of product recalls or field safety corrective actions initiated by your business unit.
Target · Maintain zero Class I or Class II recalls; reduce Class III recalls by 25% year-on-year.

Successfully launch three new products without any market withdrawals or safety alerts within their first year.

Proactive Risk Mitigation
How effectively you identify and address potential quality and regulatory risks before they become problems, rather than just reacting.
  • Regular updates to the business unit's risk register, evidence of preventative actions implemented (e.g., process changes, training programmes), positive feedback from internal audit on risk anticipation.
Cross-functional Influence & Collaboration
Your ability to get different departments (like R&D, Operations, Sales) to buy into and actively support quality and compliance initiatives.
  • Being consistently sought out for input on new product development or process changes, successful implementation of quality improvements that required significant cross-departmental effort, positive feedback in 360-degree reviews from peer leaders.
Regulatory Body Relationship Management
The strength and effectiveness of your relationships with key regulatory agencies and external auditors.
  • Smooth, professional interactions during inspections, successful negotiation of compliance timelines, being seen as a credible and trustworthy counterpart by regulators, positive feedback from legal counsel on interactions.
Talent Development & Team Leadership
How well you build, mentor, and retain a high-performing quality and regulatory team.
  • Low attrition rates within your direct and indirect teams, successful internal promotions, clear succession plans for key roles, positive feedback from your team members in engagement surveys, measurable improvements in team capabilities.

7Would you like it

Both sides. What people enjoy, and what grinds them down.

What people enjoy
Protecting the Business & Public

You'll feel a deep sense of purpose knowing your work prevents harm to customers, protects our brand, and ensures the company's long-term viability. This shows up in your meticulous review of audit reports, your insistence on thorough investigations, and your commitment to robust preventative measures.

Successfully implementing a new supplier quality programme that drastically reduces incoming material defects, directly preventing potential product failures in the market.

Driving Strategic Organisational Change

You're energised by the challenge of transforming how an entire business unit approaches quality and compliance. This means you'll be actively designing new systems, challenging old ways of working, and championing cultural shifts, rather than just maintaining the status quo.

Leading the successful implementation of a new QMS across the business unit, which fundamentally changes how quality data is collected, analysed, and acted upon.

Solving Complex, Multi-faceted Problems

You thrive on tackling ambiguous, high-stakes problems that require integrating regulatory knowledge, business acumen, and technical expertise. You enjoy dissecting complex issues, finding root causes, and crafting elegant, sustainable solutions.

Investigating a series of seemingly unrelated customer complaints and discovering a systemic design flaw that requires a cross-functional engineering and quality effort to resolve.

What frustrates people
  • The constant battle against the perception that Quality is a roadblock, not an enabler.
  • Having to justify investment in preventative measures when the 'cost of doing nothing' isn't immediately visible.
  • Dealing with superficial investigations that blame 'human error' instead of finding true systemic root causes.
  • Navigating internal politics when audit findings put a senior leader's project on hold.
  • The sheer volume and complexity of ever-changing global regulations, and the challenge of keeping everyone up to date.
What this role does not give you
  • A quiet, low-stress environment – this is high-stakes, high-pressure work.
  • The ability to always be popular – you'll often have to deliver tough messages.
  • A role where you only focus on technical details – you'll need to be a business leader first.
  • Immediate, tangible results for every single initiative – some changes take years to fully embed.

8Who you work with

This role directly shapes the compliance culture and risk profile of a significant business unit. Your strategic decisions impact everything from product design and manufacturing processes to market access and customer trust. Get it right, and you're a key enabler of sustainable growth; get it wrong, and you're looking at major business disruption and financial losses. You're essentially the guardian of our license to operate within your domain.

Inside the business
  • Business Unit Leadership Team (e.g., MD, Head of Operations, R&D Director)
  • Global Quality & Compliance Leadership (CQO, other VPs/Directors)
  • Legal Counsel
  • Product Development & Engineering Teams
  • Sales & Marketing Leadership
Outside the business
  • Regulatory Bodies (e.g., MHRA, HSE, FDA, EMA)
  • External Auditors & Certification Bodies
  • Key Suppliers & Contract Manufacturers
  • Industry Associations & Standard-Setting Organisations

9What you need before you start

Not a wish list. The things you would be expected to already have.

  • Extensive experience (16+ years) in senior leadership roles within Quality Assurance, Regulatory Affairs, or Compliance, preferably within a highly regulated industry.
  • Demonstrable track record of leading and developing large, multi-disciplinary teams, including managers.
  • Proven experience in managing significant P&L responsibilities (e.g., £2M-£10M+) for quality or compliance functions.
  • Direct experience successfully managing major regulatory inspections and interacting with senior regulatory officials.
  • A deep, practical understanding of enterprise-level Quality Management Systems (QMS) and their strategic implementation.
  • Strong business acumen, with the ability to translate complex regulatory requirements into clear business strategies and financial impacts.
  • A Master's degree in a relevant scientific, engineering, or business discipline, or equivalent extensive practical experience.

10What to practise next

Where the job is going, and what to do about it starting this week.

Advanced Data Analytics & Visualisation for Strategic Insights

Simply reporting data isn't enough. You need to tell a compelling story with data, identifying hidden trends, predicting future risks, and justifying strategic investments. This means moving beyond basic dashboards to sophisticated analytical models.

Statistical Process Control (SPC) for Predictive Quality · Root Cause Analysis (RCA) with Machine Learning · Data Storytelling for Executives · Benchmarking & Competitive Intelligence with Data

  • This quarter: Work closely with your data analytics team to understand their capabilities and how they can better support your strategic reporting needs.
  • Next 6 months: Identify one key business unit metric (e.g., COPQ) and challenge your team to build a predictive model for it, rather than just retrospective reporting.
  • Next 12 months: Lead a project to integrate disparate quality and safety data sources into a unified data lake for more comprehensive analysis.
  • Ongoing: Seek out executive training on 'Data Storytelling' or 'Analytics for Leaders' to refine your ability to communicate data-driven insights.

Quick win: Challenge your team to identify three 'hidden insights' from existing quality data that haven't been acted upon. This will push them (and you) to think more analytically about the data you already have.

11Staying current once you are in

What people here do to keep up
  • Regularly attend industry conferences and workshops focused on regulatory updates, emerging quality technologies (e.g., AI in QA), and best practices in compliance.
  • Actively participate in industry associations and working groups to stay ahead of regulatory changes and influence future standards.
  • Engage in executive leadership development programmes to hone your strategic thinking, influence, and team leadership skills.
  • Seek out opportunities for cross-functional leadership roles or projects that broaden your business acumen beyond pure quality and regulatory.

12The rising capability

The rising capability

Zavmo analysis

What's rising in its place

This is where the work is heading, and the higher pay with it. Get fluent here and the shift stops being a threat and starts being your edge.

AI & Automation Strategy for Compliance

AI is no longer just for data scientists; it's transforming how we manage compliance. Competitors are already using AI to automate routine checks, predict risks, and streamline documentation. Directors who don't embrace this will find their functions slow, expensive, and less effective.

  • AI Governance & Ethics
  • Process Mining for Compliance
  • Predictive Compliance Modelling
  • Regulatory Change Impact Analysis (Automated)

ESG (Environmental, Social, Governance) Integration

ESG is no longer a 'nice-to-have'; it's a critical driver of investor confidence, brand reputation, and regulatory scrutiny. Quality and compliance leaders will increasingly be responsible for integrating ESG metrics and reporting into their existing frameworks, ensuring ethical and sustainable operations.

  • ESG Reporting Frameworks (e.g., GRI, SASB)
  • Supply Chain Due Diligence (Social & Environmental)
  • Carbon Footprint Measurement & Reduction
  • Ethical AI & Data Governance

13What you’ll use

What you’ll use

Skills this role draws on

Technical

  • ISO Standards Mastery (9001, 14001, 45001)
  • Advanced CAPA System Management
  • Lean Six Sigma (Master Black Belt equivalent)
  • Enterprise Risk Management & FMEA
  • Audit Programme Design & Oversight

14The pathway

The pathway

How you actually get there, here

How you become one varies far more by country than what one does. This is the UK route. Most people take one of these ways in; the right one depends on where you're starting from.

  1. 1

    From Senior Quality & Compliance Manager (L5)

    3-5 years as an L5 manager.

    Skills to master

    • Moving from managing a single site or function to overseeing a broader business unit. This means developing a more strategic mindset, managing managers, and demonstrating a clear ability to influence at the executive level. You'll need to show you can handle larger budgets and more complex regulatory landscapes.

    You're ready to move on when

    • Successfully led a major quality system upgrade or regulatory compliance project across multiple sites.
    • Consistently exceeded performance targets for your managed function (e.g., reduced COPQ, improved audit outcomes).
    • Developed and mentored multiple individuals into management roles.
    • Demonstrated strong relationships and influence with business unit leadership and external stakeholders.
  2. 2

    From Principal Compliance Specialist (L4) with Team Lead Experience

    5-7 years as an L4 specialist, including significant team leadership.

    Skills to master

    • This path requires a significant leap in leadership and strategic scope. You'll need to transition from architecting systems to leading entire functions and people. Developing strong P&L management skills, executive communication, and a proven ability to drive cultural change are crucial.

    You're ready to move on when

    • Designed and implemented a critical enterprise-wide quality subsystem that had significant business impact.
    • Successfully led a cross-functional team through a major regulatory inspection with excellent outcomes.
    • Took on interim leadership roles, demonstrating the ability to manage a full function.
    • Actively sought out and delivered presentations to senior leadership, showcasing strategic thinking.
  3. 3

    From Regulatory Affairs Director (External)

    Direct entry if experience aligns.

    Skills to master

    • If you're coming from a pure Regulatory Affairs background, you'll need to demonstrate a strong understanding of broader Quality Management Systems (QMS) and operational quality. Vice versa if you're coming from a pure Quality background. A blend is ideal, but a strong strategic mindset and leadership track record can bridge gaps.

    You're ready to move on when

    • Proven track record of successful regulatory approvals and post-market compliance in a similar industry.
    • Experience managing a team of regulatory professionals.
    • Strong understanding of the interplay between regulatory affairs and quality assurance.
    • Demonstrated ability to operate at a strategic level within a complex organisation.

15Where this role leads

The long view: This role can lead to positions such as Chief Quality Officer or Chief Risk Officer, overseeing quality and risk across an entire organisation.

The ten Future Fluencies

Zavmo analysis

The credential is what you can do today. These are what keep you valuable.

A qualification proves you can do the job as it's defined today. These ten are what decide whether you're still the obvious person for it in five years. They're the capabilities employers are now writing into senior roles faster than people are learning them. Zavmo weaves them through whatever you study, so you come out with both: the credential and the fluency.

The highlighted ones are the Fluencies your role leans on hardest, from how Director of Quality & Regulatory Affairs is actually changing.

Where it leads

Roles this leads to

The record names a next step, but the catalogue has no page for it yet:

  • Chief Quality Officer (CQO) / VP Global Quality & Regulatory Affairs (L7)
  • Business Unit Managing Director / General Manager

How you would learn this

One to one, on the work you already do

A tutor sets the task against your own job and marks the reasoning, at your pace. There is no cohort to fall behind.

A lesson from Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety, worked against Director of Quality & Regulatory Affairs.

Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety Level 5

Applied to your work in Director of Quality & Regulatory Affairs

The objective of this unit is to provide learners with a comprehensive understanding of the regulations, industry standards, and management requirements for process safety. Learners will understand the role of the Process Safety Leadership Group, relevant frameworks, legal duties, and the role of the Competent Authority.

How the thinking builds
  1. 1 Remember
  2. 2 Understand
  3. 3 Apply
  4. 4 Analyse
  5. 5 Evaluate
  6. 6 Create
An illustration of a Zavmo lesson, built from this role’s own route. The unit, its objective and every criterion above are the awarding body’s own words, not an example.

It is £70 a month, billed monthly. Your free first module is Future Fluency, and you can cancel any time.

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See Your Progress Grow Illustration
Director of Quality & Regulatory Affairs
  • ISO Standards Mastery (9001, 14001, 45001)
  • Advanced CAPA System Management
  • Lean Six Sigma (Master Black Belt equivalent)
  • Enterprise Risk Management & FMEA
  • Audit Programme Design & Oversight
This is your Mind Palace on learn.zavmo.ai. Every skill above comes from this role's own record, not an example borrowed from another job. A node lights up when you evidence it, and what you build stays yours between jobs. That is the part a course cannot do.

16The detail, folded away

Everything else the record holds

The career branches in full, how AI is already showing up in the day-to-day, and the questions people ask about this job. Here when you want them, out of the way while you decide.

Where it leads next, rung by rung

Where it leads

The career path, and where it branches

Director of Quality & Regulatory Affairs is a start, not a ceiling. Each step below asks for new skills and hands back more autonomy.

  1. Chief Quality Officer (CQO) / VP Global Quality & Regulatory Affairs (L7)

    5-8 years in the Director role.

    This is the ultimate step up, moving from business unit responsibility to enterprise-wide leadership. You'll report directly to the CEO or Board, setting global quality policy and strategy.

    • Global Quality System Architecture Designing and implementing a unified QMS across all business units and geographies.
    • Enterprise Risk Management (ERM) Leading the overall ERM framework, integrating quality and compliance risks into the company's total risk profile.
    • Public Relations & Crisis Management Acting as a company spokesperson during major quality or safety incidents, managing public perception.
    • Industry Thought Leadership Representing the company on industry boards and influencing future standards.

  2. Business Unit Managing Director / General Manager

    4-7 years in the Director role.

    This is a lateral move into broader business leadership, leveraging your deep understanding of operational excellence, risk management, and regulatory frameworks to lead an entire business unit.

    • Commercial Strategy Development Defining pricing, market entry, and sales channel strategies.
    • Supply Chain Optimisation End-to-end management of the supply chain, from procurement to logistics.
    • Organisational Design & Development Structuring and scaling entire business units.
    • Investor Relations (BU-specific) Communicating business unit performance to investors and analysts.
Working with AI on the job

Working with AI

Where AI is starting to help

Let's be real, as a Director, your time is precious. You shouldn't be drowning in manual reviews or chasing down basic information. AI isn't here to replace you; it's here to amplify your strategic output, letting you focus on the big picture and driving real change.

Imagine having a personal assistant that can sift through mountains of regulatory updates, summarise complex audit reports, and even help you draft board presentations. That's the reality with AI. We're not just talking about minor tweaks; we're talking about a fundamental shift in how you lead your quality and regulatory function, giving you back hours every week to focus on what truly matters: strategy, people, and critical risk mitigation.

Predictive Risk Identification

AI analyses data from all your systems (QMS, EHS, ERP, customer complaints) to spot subtle, emerging risks across your business unit before they blow up. It'll flag potential quality issues, safety hotspots, or compliance gaps that human analysis alone might miss. This means you can proactively intervene, saving millions and protecting our reputation.

Global Regulatory Intelligence Briefs

Forget spending hours sifting through dozens of regulatory websites. AI continuously monitors global agencies, summarising proposed rule changes, new guidance, and enforcement actions relevant to your specific products and markets. You'll get concise, actionable daily or weekly briefs, keeping you informed without the information overload.

Board Report & Presentation Drafting

AI can help you draft sections of your quarterly quality and safety reports for the Board. Feed it raw data, key findings, and strategic objectives, and it'll generate initial text, executive summaries, and even suggest visualisations. You'll spend less time on drafting and more time refining the message and preparing for tough questions.

Automated Compliance Audits (Pre-Audit Checks)

Before an external audit, AI can perform a 'pre-audit' by scanning internal documents, training records, and process logs against regulatory requirements. It'll highlight potential gaps or inconsistencies, allowing your team to proactively address them, ensuring you're truly 'audit-ready at all times'.

Common questions

Common questions

How do you become a Director of Quality & Regulatory Affairs?

Common routes in include From Senior Quality & Compliance Manager (3-5 years as an L5 manager.), From Principal Compliance Specialist with Team Lead Experience (5-7 years as an L4 specialist, including significant team leadership.) and From Regulatory Affairs Director (External) (Direct entry if experience aligns.). Times vary with prior experience.

Where can a Director of Quality & Regulatory Affairs progress to?

This role can lead on to Chief Quality Officer (CQO) / VP Global Quality & Regulatory Affairs (5-8 years in the Director role.) and Business Unit Managing Director / General Manager (4-7 years in the Director role.), depending on the skills you build.

What new skills matter most for a Director of Quality & Regulatory Affairs?

Increasingly, AI & Automation Strategy for Compliance and ESG (Environmental, Social, Governance) Integration. These are the skills our record of this role lists as growing.

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17Where to go from here

Other roles at Level 7

Same depth of qualification, different job. Useful if the work appeals but this particular role does not.

 More jobs in compliance, quality and safety

Stay in the field you know and move sideways rather than up.
If you leave this industry

Expertise in quality, safety, and regulatory compliance applies across regulated industries, including pharmaceuticals, medical devices, aerospace, automotive, food and beverage, and financial services. The principles of risk management, process control, and regulatory adherence carry across many sectors.

This role profile is © 2026 Growth Engineering Technologies Ltd. Built from UK occupational standards and regulated qualification data, and written for Zavmo.

You're not behind. You're right on time. The shift is only just beginning. Your role won't look the same in two years. Be the one who leads the change, not the one it happens to. Start my plan, free What happens next: a free account, then we build your plan as you set up. No card. Build your plan, see your roadmap and meet the twelve tutors matched to you. All free. When you're ready to start learning, it's £70 a month, billed monthly. Cancel any time and billing stops.