Associate Director of Regulatory Medical Writing

You will work closely with cross-functional teams to ensure timely and accurate submissions to regulatory authorities.

• Lead the preparation and review of complex regulatory documents, including INDs, NDAs, and clinical study reports.
• Collaborate with project teams to develop writing strategies that align with clinical and regulatory objectives.
• Mentor and guide team members in best practices for regulatory writing and compliance.
• Maintain up-to-date knowledge of regulatory guidelines and industry trends specific to oncology.
• Engage with regulatory agencies as needed to facilitate the submission process.

• Master's degree in Life Sciences, Medicine, or a related field (PhD or MD preferred).
• 7+ years of experience in regulatory medical writing, especially in the oncology sector.
• Ideally experience working in Biotechnology or pharmaceutical company - CRO and Consultancy can be considered
• Track record of successful regulatory submissions to FDA and EMA.
• Strong understanding of FDA/EMA guidelines and requirements for oncology.
• Excellent written and verbal communication skills, with a focus on clarity and precision.
• Demonstrated leadership and mentoring abilities.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Willingness to participate in occasional travel for team meetings or regulatory engagements.

• Very competitive Basic Salary
• Up to 18% annual performance bonus
• Stocks options and LTI programs
• Home office Allowance
• Annual company offsite holiday
• Mental health awareness - 8 company-paid therapy sessions a year
• Sports Club & Gym membership
• 100% paid medical insurance
• 401(k) program