Senior Manager / Associate Director RA

Medella Life; Massachusetts; On-site; USD 150,000 - 210,000; Full time

Job summary

Medella Life is seeking a highly motivated Senior Manager / Associate Director, Regulatory Affairs to lead regulatory strategy across a growing biopharmaceutical pipeline. The role will involve significant exposure to the FDA and Health Authorities, with ownership of strategy and submissions in a dynamic biotech environment.

The position requires 7+ years in Regulatory Affairs, strong US regulatory experience, and NDA/BLA familiarity.

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• 7+ years of pharmaceutical/biotech Regulatory Affairs experience.
• Strong experience with US regulatory strategy and FDA interactions.
• Demonstrated experience supporting or leading IND submissions.
• NDA/BLA experience desirable.

Responsibilities

• Develop and execute regulatory strategies from pre-IND through clinical development and registration.
• Lead and support INDs, amendments, briefing documents, meeting requests, and FDA/Health Authority submissions.
• Support preparation for FDA and global Health Authority meetings.
• Provide regulatory guidance to cross-functional teams (Clinical, CMC, Quality, Nonclinical, Medical).
• Develop regulatory plans aligned with milestones and study plans.
• Review regulatory input into protocols, study plans, CMC docs and investigator materials.
• Coordinate submission activities and ensure high-quality, timely deliverables.
• Contribute to global regulatory strategies across US, EU and other markets.
• Monitor regulatory developments and provide regulatory intelligence to stakeholders.
• Identify regulatory risks and develop practical mitigation strategies.
• Manage external regulatory consultants and vendors as needed.
• Support regulatory due diligence and business development.
• Contribute to development of Regulatory Affairs processes, systems and SOPs.
• Provide mentorship and leadership to junior regulatory professionals as appropriate.

Skills

Regulatory strategy

FDA interactions

Regulatory submissions

Regulatory writing

Project management

Mentorship

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

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 Responsibilities

• Develop 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 & Experience

• Bachelor'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.