The Opportunity:

As part of our expanding European organization, we are seeking an experienced Principal Regulatory Medical Writer to support the preparation of high-quality regulatory documentation for clinical development and marketing authorization activities across Europe. Working closely with Regulatory Affairs, Clinical Development, Clinical Operations, Biometrics, Pharmacovigilance, CMC, and other cross-functional teams, the successful candidate will author, coordinate and finalize regulatory documents supporting interactions with European and international Health Authorities.

The candidate will serve as the lead author for complex regulatory documents and will ensure documents are scientifically accurate, strategically aligned, compliant with ICH, EU and applicable regional requirements, and submission-ready.

The successful candidate will play a key role in supporting regulatory interactions with European Health Authorities by developing clear, scientifically robust, and strategically aligned regulatory documentation throughout the product lifecycle.

The role will report to the VP, Regulatory Affairs, Europe.

Primary Responsibilities:

• Author, edit and coordinate high-quality clinical regulatory documents, including:

• Responses to Health Authority questions (EMA, MHRA, Swissmedic, etc).

• Scientific Advice briefing books and meeting packages.

• Risk Management Plan (RMP).

• Periodic safety documents (as applicable).

• As needed, serve as a medical writing lead for complex clinical regulatory documents, supporting clinical development including protocols, IBs, CSRs, and CTA modules.

• Other regulatory documents supporting lifecycle management, variations and renewals.

• Coordinate preparation of responses to regulatory agency requests for information, ensuring consistency across multidisciplinary functional contributions.

• Lead document planning, review cycles, comment resolution and finalization while ensuring adherence to project timelines.

• Collaborate closely with Global and European Regulatory Affairs to ensure documents support the overall regulatory strategy.

• Ensure all documents comply with applicable ICH guidelines, EMA guidance, GCP, company standards and document templates.

• Facilitate document review meetings and manage cross-functional comment adjudication.

• Identify potential scientific or regulatory inconsistencies and work with subject matter experts to resolve issues.

• Maintain consistency across related submission documents and across development programs.

• Support development and continuous improvement of medical writing processes, templates, style guides and standard operating procedures.

• Mentor junior writers when appropriate and contribute to departmental best practices.

The candidate must have a thorough understanding of oncology drug development, applicable European regulations and guidelines.

Required Skills, Experience and Education:

• Advanced degree (PhD, PharmD, MD, MSc or equivalent) in life sciences or a related scientific discipline.

• Minimum 10+ years of regulatory medical writing experience within the biotechnology or pharmaceutical industry.

• Demonstrated experience authoring documents supporting European regulatory submissions.

• Experience preparing responses to Health Authority questions during CTA, MAA or post-approval procedures.

• Thorough understanding of:

  • ICH guidelines (including E3, M4, E6)

  • EU Clinical Trial Regulation (EU CTR 536/2014)

  • EMA regulatory procedures

  • GCP principles

• Strong scientific writing and editing skills with exceptional attention to detail.

• Excellent project management and organizational skills.

• Ability to manage multiple simultaneous projects in a fast-paced environment.

• Strong interpersonal and communication skills with demonstrated ability to work across multidisciplinary global teams.

• Excellent written and verbal English.

Preferred Skills:

• Oncology regulatory writing experience.

• Experience supporting EMA Scientific Advice and/or Marketing Authorisation Applications.

• Experience with centralized, decentralized or national European regulatory procedures.

• Experience with eCTD submissions.

• Familiarity with Veeva Vault RIM, StartingPoint, EndNote, SmartSheet and document management systems.

• Experience performing quality control reviews of regulatory documents.

• Experience working within small or mid-sized biotechnology companies.

• Experience supporting European regulatory submissions.

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