Senior Regulatory Writer

Senior Regulatory Writer – remote

SUMMARY:

• 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

Regulatory Writing, Briefing, and Reviewing

• 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

Education:

• BSc, MSc, or PhD in a life sciences or medically related field (required).

Experience:

• 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