Job Description
Are you ready to accelerate the delivery of life-saving oncology therapies? Aegis Biopharma is seeking an experienced, visionary Senior Regulatory Affairs Manager to lead strategic global submissions and shape the future of our oncology pipeline.
In this high-impact role, you will serve as the primary liaison with regulatory authorities, including the FDA and EMA, orchestrating successful IND, NDA, and BLA filings. Joining our Boston-based innovation hub, you will work collaboratively with cross-functional clinical, non-clinical, and CMC teams to transition cutting-edge science into transformative patient care.
We offer a collaborative ecosystem, state-of-the-art resources, and a trajectory-altering career path for industry leaders committed to scientific excellence and patient safety.
Responsibilities
- Lead the preparation, review, and timely submission of high-quality regulatory dossiers, including INDs, NDAs, BLAs, and MAAs, for oncology candidates.
- Serve as the primary point of contact with regulatory bodies, directing pre-IND, end-of-phase, and pre-NDA meetings.
- Provide strategic regulatory guidance to cross-functional clinical development, non-clinical, and CMC project teams.
- Monitor evolving global regulatory requirements and perform impact assessments on active clinical development programs.
- Oversee the lifecycle management of existing approvals, ensuring strict compliance with post-marketing requirements.
- Coordinate with external regulatory consultants and international partners to align global registration pathways.
Qualifications
- Bachelor's degree in a scientific discipline, with a Ph.D., PharmD, or Master's degree highly preferred.
- Minimum of 6+ years of regulatory affairs experience within the pharmaceutical or biotechnology sector.
- Proven track record of successful IND/NDA/BLA submissions, specifically with a focus on oncology.
- Direct, successful experience leading interactions and negotiations with the FDA and EMA.
- Deep understanding of ICH guidelines, FDA regulations, and global regulatory frameworks.
- Exceptional project management, communication, and cross-functional leadership skills.