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Senior Regulatory Writer REMOTE

Meet Life Sciences
London
6 days ago
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Matching professionals with opportunities within the life sciences sector

We’re currently collaborating with a global, award-winning medical communications agency to support their search for an experienced

Senior Regulatory Medical Writer . This is a unique opportunity to join a high-performing regulatory writing team, with exposure to international projects, complex document types, and strategic input in client programs.
About the Role:
As a Senior Regulatory Medical Writer, you will independently lead the development of a wide range of core regulatory documents across various therapeutic areas. You’ll act as a primary point of contact for clients, support junior writers, and provide critical input on project strategy and delivery — all while working in a collaborative and supportive environment.
This role is ideal for a confident communicator and experienced writer who thrives on ownership, autonomy, and the opportunity to mentor others.
Key Responsibilities:
Independently produce a range of high-quality regulatory documents (e.g., CSRs, protocols, IBs, CTD summaries, narratives)
Critically review and provide strategic input into client documentation
Act as a lead writer across multiple projects, overseeing timelines, quality, and team resourcing
Coach and mentor junior writers, contributing to team knowledge sharing and best practice
Serve as the expert point of contact for both internal stakeholders and external clients
Participate in client meetings and proactively address issues and risks
Ensure compliance with SOPs, industry regulations, and document standards
Ideal Candidate Profile:
Minimum of 5 years' regulatory writing experience in a medical communications agency or pharma/biotech setting
Proven experience as lead writer across at least 3 document types (e.g., protocols, CSRs, IBs, Module 2.7 documents)
BSc or PhD in life sciences (PhD preferred)
Strong understanding of ICH and regulatory authority requirements
Experience managing client relationships and project timelines
Comfortable mentoring junior writers and delegating tasks effectively
Ability to work independently and lead document strategy discussions
Exceptional written and verbal communication skills
What’s on Offer:
Work with a global client base across therapeutic areas
Highly supportive team culture and leadership
Flexible/hybrid working options
Strong focus on professional development and mentoring
Opportunities for strategic project involvement and business development exposure
Career progression pathways within a growing team
Seniority level

Seniority level Not Applicable
Employment type

Employment type Full-time
Job function

Job function Health Care Provider
Industries Pharmaceutical Manufacturing
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