Senior Regulatory Writer REMOTE

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