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
Associate Submissions Coordinator (L1)
1-2 yearsSkills to master
- Document formatting, basic QC, understanding eCTD structure, using document management systems under supervision.
You're ready to move on when
- Consistently produces error-free documents for simple submissions.
- Can independently perform all steps of a basic QC checklist.
- Demonstrates a solid understanding of internal SOPs and GDocP.
- Proactively asks clarifying questions and shows initiative in learning new processes.
- 2
Regulatory Affairs Assistant / Administrator
2-3 yearsSkills to master
- General regulatory support, document control, basic regulatory intelligence research, coordinating with internal teams.
You're ready to move on when
- Has a good overview of the regulatory landscape and agency requirements.
- Is highly organised and capable of managing multiple administrative tasks efficiently.
- Shows strong attention to detail in all documentation tasks.
- Has experience chasing and coordinating information from various internal stakeholders.
- 3
Document Control Specialist (within a GxP environment)
2-4 yearsSkills to master
- Document version control, audit trail maintenance, electronic document management systems, GDocP principles.
You're ready to move on when
- Expertise in managing controlled documents within a regulated industry.
- Deep understanding of document lifecycles and archiving requirements.
- Proven ability to maintain meticulous records and ensure data integrity.
- Familiarity with electronic document management systems and their workflows.