Senior Regulatory Writer

Independently produce high-quality core regulatory documents that meet or exceed expectations, delivered on time and within budget. Provide value to clients, colleagues, and the wider business through proactive contributions. Take ownership of key regulatory writing deliverables with autonomy, ensuring clarity, accuracy, and objectivity. Recognized as a subject matter expert and primary point of contact across multiple document types and projects. Mentor and guide junior writers, delegate appropriately, and contribute to a collaborative team environment.

KEY RESPONSIBILITIES

• Lead the development of regulatory documents that are scientifically sound and aligned with submission goals.
• Provide project-level guidance to team members, including client-specific expectations and document strategies.
• Critically evaluate client-supplied materials and clinical data to produce compliant, well-written outputs.
• Advise clients and colleagues based on knowledge of regulatory requirements and submission strategy.
• Manage source materials, version control, and filing in accordance with established SOPs.
• Perform document reviews and data quality checks; support or lead QC efforts across deliverables.
• Lead or contribute to project kickoffs, timelines, and resource planning.

Team Collaboration

• Actively support and collaborate with colleagues across writing projects.
• Delegate document components or tasks to less experienced writers when appropriate.
• Share knowledge through mentoring, peer review, and best-practice discussions.

Client Service & Relationship Management

• Serve as a confident, knowledgeable contact for clients.
• Facilitate productive client meetings and resolve project issues collaboratively.
• Build trust through reliable, high-quality delivery and strategic insight.

Project & Financial Management

• Monitor project scope and cost against budget; escalate or negotiate amendments as necessary.
• Align deliverables to contractual obligations and track effort for billing purposes.
• Support commercial awareness through accurate time reporting and schedule management.

Business Development (as applicable)

• Contribute to relationship-building with new and existing clients.
• Support identification of new project opportunities or extensions.

QUALIFICATIONS

• BSc, MSc, or PhD in a life sciences or medically related field (required).
• Proven experience as a lead author on multiple regulatory documents, including at least 3 of the following: protocols, clinical study reports, clinical summaries, clinical overviews, investigator brochures, narratives, briefing documents, or regulatory response documents.
• Experience leading projects and managing client relationships in a regulatory writing context.

SKILLS & COMPETENCIES

• Deep understanding of regulatory requirements for core documents (e.g., ICH guidelines, CTD structure).
• Ability to lead writing activities with minimal oversight, especially for clinical regulatory documents.
• Skilled in document strategy, content planning, and scientific interpretation.
• Strong project management and organizational skills.
• Confident communicator with strong interpersonal abilities.
• Proficient in reviewing peer documents and providing constructive feedback.
• Adept at managing multiple projects and timelines concurrently.
• Demonstrates leadership qualities and fosters development of junior team members.
• Committed to continuous learning and personal development.

BENEFITS

• Unlimited Holiday Policy (including office closure between Christmas and New Years)
• Open to part-time work
• Bonus scheme
• Healthcare
• Pension
• Flexible working hours
• Extensive training development