Job Description
We are looking for a visionary Senior Regulatory Affairs Specialist to drive the regulatory strategy for our next-generation therapeutics. At Novaris Therapeutics, we don't just follow guidelines; we define the future of patient access through innovative compliance frameworks. Based in our state-of-the-art facility in Boston, you will bridge the gap between scientific innovation and regulatory success, ensuring our products reach patients safely and efficiently.
Why Join Our Team?
- Work on groundbreaking science that changes lives.
- Competitive compensation and comprehensive benefits package.
- Opportunities for continuous learning and professional development.
Responsibilities
- Direct the end-to-end lifecycle of regulatory submissions, including IND, NDA, BLA, and MAA filings to the FDA and EMA.
- Act as the primary regulatory contact for health authority interactions and audits.
- Develop and maintain robust regulatory strategies for global market access.
- Oversee the preparation of complex technical dossiers and supporting documentation.
- Collaborate with Clinical, Quality, and Manufacturing teams to ensure alignment on regulatory requirements.
Qualifications
- Master’s degree in a scientific discipline or equivalent regulatory affairs certification (RAC) is highly preferred.
- 7+ years of progressive experience in pharmaceutical regulatory affairs, preferably within a biotech setting.
- Deep understanding of the FDA Code of Federal Regulations (CFR) and ICH guidelines.
- Demonstrated success in managing multi-country registration strategies.
- Exceptional project management skills with the ability to handle high-pressure deadlines.