Senior Manager / Associate Director RA

We are seeking a highly motivated Senior Manager / Associate Director, Regulatory Affairs to support the development and execution of regulatory strategy across a growing biopharmaceutical pipeline.
The position will have significant exposure to the FDA and other Health Authorities and will offer the opportunity to take ownership of regulatory strategy and submissions within a growing biotech environment.
Key ResponsibilitiesDevelop and execute regulatory strategies across assigned programs from pre-IND through clinical development and registration.Lead and support INDs, IND amendments, briefing documents, meeting requests, responses to Health Authority questions and other regulatory submissions.Support preparation for and participation in FDA and global Health Authority meetings.Provide regulatory guidance to cross-functional teams across Clinical, CMC, Quality, Nonclinical and Medical.Develop regulatory plans aligned with key clinical and development milestones.Review and provide regulatory input into clinical protocols, study plans, CMC documentation, investigator materials and other development documents.Coordinate submission activities and ensure high-quality, timely regulatory deliverables.Contribute to global regulatory strategies across the US, EU and other key markets.Monitor regulatory developments and provide relevant regulatory intelligence to internal stakeholders.Identify regulatory risks and develop practical strategies to address them.Manage external regulatory consultants and vendors where appropriate.Support regulatory due diligence and business development activities.Contribute to the development of Regulatory Affairs processes, systems and SOPs as the organization scales.Depending on experience, provide mentorship and leadership to junior regulatory professionals.
Qualifications & ExperienceBachelor's degree in a scientific or related discipline; advanced degree preferred.7+ years of pharmaceutical or biotechnology Regulatory Affairs experience.Strong experience with US regulatory strategy and FDA interactions.Demonstrated experience supporting or leading IND submissions.Experience across clinical-stage drug development, with NDA/BLA experience highly desirable.Understanding of CMC, clinical and nonclinical regulatory requirements.Experience working cross-functionally within a biotech or pharmaceutical organization.Strong knowledge of FDA regulations, ICH guidelines and applicable global regulatory requirements.Excellent regulatory writing, communication and project-management skills.Ability to work independently, prioritize multiple projects and operate effectively in a fast-paced environment.