Job Description
Are you a detail-oriented regulatory professional ready to drive innovation in the pharmaceutical industry? BioGenix Therapeutics is seeking a visionary Senior Regulatory Affairs Specialist to join our elite regulatory team in Boston.
At BioGenix, we are dedicated to accelerating the development of life-changing therapies. As a Senior Regulatory Affairs Specialist, you will play a pivotal role in the lifecycle management of our drug candidates, ensuring compliance with global health authority requirements and guiding our products from preclinical trials to market approval.
Why Join Us?
- Work with cutting-edge technologies and world-class scientists.
- Competitive salary and comprehensive benefits package.
- Opportunities for professional growth and leadership development.
- Flexible work environment and remote-first culture.
Responsibilities
- Lead the preparation, coordination, and submission of Regulatory Affairs documents, including INDs, NDAs, and BLAs to the FDA and EMA.
- Manage the regulatory lifecycle for assigned product portfolios, ensuring timely responses to health authority inquiries and FDA inspections.
- Collaborate cross-functionally with Clinical, CMC, and Safety teams to ensure regulatory requirements are integrated into all development phases.
- Maintain and update the Master File System, ensuring all documentation is accurate, accessible, and compliant with 21 CFR Part 11.
- Conduct regulatory gap analyses and develop strategies to achieve successful marketing authorization in key international markets.
- Represent BioGenix at external meetings and conferences, maintaining strong relationships with regulatory authorities and consultants.
Qualifications
- Master’s degree in Pharmacy, Biology, Chemistry, or related scientific discipline (PharmD, PhD, or MBA preferred).
- Minimum of 5+ years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology sector.
- Deep understanding of US FDA regulations (21 CFR Parts 312, 314, 601) and EMA guidelines.
- Proven track record of successful regulatory submissions and approval of NDA/BLA products.
- Excellent written and verbal communication skills, with the ability to influence cross-functional teams.
- Proficiency in regulatory software (e.g., RIM, Veeva Vault) and MS Office Suite.