Job Description
Are you a strategic thinker ready to shape the future of healthcare? BioGenix Innovations is seeking a highly skilled Senior Regulatory Affairs Specialist to join our dynamic team in Boston, MA.
We are pioneers in biopharmaceutical innovation, dedicated to developing breakthrough therapies that improve patient outcomes. In this pivotal role, you will lead regulatory strategies to navigate complex approval processes, ensuring our products reach the market safely and efficiently.
Why Join Us?
- Competitive salary and comprehensive benefits package.
- Work in a state-of-the-art facility in the heart of Boston's biotech hub.
- Opportunities for professional development and leadership growth.
Responsibilities
- Lead the end-to-end preparation and submission of regulatory dossiers, including INDs, NDAs, and BLAs to the FDA and global health authorities.
- Manage the regulatory lifecycle for clinical trials, ensuring full compliance with 21 CFR Part 11 and GMP guidelines.
- Act as the primary point of contact for cross-functional teams (R&D, Quality, Clinical) regarding regulatory requirements and submission timelines.
- Monitor global regulatory landscapes and interpret changes to impact internal product strategies.
- Coordinate with external consultants and regulatory agencies to resolve complex compliance issues.
Qualifications
- Master’s degree in Pharmacy, Life Sciences, or a related field; PhD preferred.
- Minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology sector.
- Deep understanding of FDA regulations, EMA guidelines, and ICH standards.
- Proven track record of successfully managing submissions and interactions with regulatory agencies.
- Exceptional analytical, writing, and communication skills with a keen attention to detail.