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