We are seeking a Director / Senior Director of Regulatory Medical Writing to lead the development of high-quality regulatory documentation supporting clinical development programmes, health authority interactions and product registrations.
Working closely with Regulatory Affairs, Clinical Development, Biostatistics, Pharmacovigilance and CMC teams, this individual will drive regulatory writing strategy, translate complex scientific and clinical data into clear regulatory narratives, and ensure submissions meet applicable regulatory requirements. This is an opportunity to shape regulatory writing strategy, processes and infrastructure within a growing biotechnology organisation.
Key Responsibilities
- Lead regulatory medical writing activities across development programmes, overseeing the preparation of INDs, CTAs, CTD/eCTD modules, amendments, annual reports, briefing documents and responses to health authority questions.
- Develop and oversee key clinical and regulatory documents, including clinical study protocols, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), safety updates and integrated summaries.
- Partner with Regulatory Affairs leadership to develop submission strategies, ensuring documents support regulatory objectives, accurately reflect programme data and maintain consistent messaging across submissions.
- Collaborate with Clinical Development, Biostatistics, Pharmacovigilance and CMC teams to critically interpret non-clinical, clinical and safety data and incorporate findings into regulatory documentation.
- Ensure the quality, accuracy, consistency and compliance of all regulatory documents with applicable FDA, EMA and ICH guidelines.
- Establish and maintain regulatory writing processes, templates, style guides, quality control standards and document management procedures to improve submission readiness and operational efficiency.
- Manage regulatory writing plans, timelines, resources and budgets, ensuring deliverables align with clinical milestones and regulatory submission deadlines.
- Lead interactions with external medical writing vendors and consultants, overseeing document quality, project delivery and adherence to regulatory requirements.
- Provide strategic input into regulatory submissions, health authority briefing packages and responses to agency questions, helping identify potential gaps and strengthen regulatory positioning.
- Lead, mentor and develop medical writing personnel, building internal capabilities and supporting the long-term growth of the regulatory writing function.
Required:
- Bachelor's, Master's or PhD in a scientific or life sciences discipline.
- 10+ years of experience in regulatory medical writing within the pharmaceutical or biotechnology industry, with additional leadership experience expected at Senior Director level.
- Extensive experience authoring and leading regulatory submissions, including INDs, CTAs, CTD/eCTD modules, amendments and annual reports.
- Strong understanding of FDA, EMA and ICH requirements, regulatory submission processes and the pharmaceutical product development lifecycle.
- Proven ability to interpret complex clinical, non-clinical and safety data and translate findings into clear, scientifically accurate and strategically aligned regulatory documents.
- Experience working closely with Regulatory Affairs and cross-functional development teams to support regulatory strategy and submission planning.
- Demonstrated experience establishing regulatory writing standards, templates, quality control processes and document management systems.
- Strong project management skills, with the ability to manage multiple submissions, competing priorities and critical deadlines.
- Excellent scientific writing, editing, analytical and communication skills, with exceptional attention to detail.
- Experience managing external vendors, allocating resources and overseeing regulatory writing deliverables.
- Proven leadership capabilities, with the ability to influence stakeholders and drive quality, consistency and continuous improvement.
Preferred:
- Previous experience within a small or mid-sized biotechnology or pharmaceutical company.
- Experience supporting programmes from early-stage development through late-stage clinical development and marketing applications.
- Experience supporting NDA, BLA or MAA submissions and responses to health authority requests.
- Experience developing or scaling an internal regulatory medical writing function.
- Experience across multiple therapeutic areas or complex biologics, small molecules or advanced therapy programmes.
