Regulatory Affairs Manager
Cambridge Metro Area, MA
- Bachelor's degree with minimum of 3 years experience in a Regulatory Affairs role; minimum of 4 years experience working in the biotech or pharmaceutical industry or allied healthcare field. Advanced Degree with RAC certification Preferred
- Experience with regulatory filings, including electronic submissions, e.g., INDs, CTAs, annual reports, safety reporting, etc.
- Work with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs, INDs), Marketing Applications, Pediatric Plans, Orphan Designation and Expedited Pathway Applications, and any amendments thereto.
- Develop detailed regulatory project plans and lead or support regulatory activities relating to specific portfolio of products/projects.
- Participate as an active team member of the Global Regulatory Teams for assigned programs and provide strategic regulatory advice to project teams as required.
- Coordinate responses to regulatory authorities questions with strict deadlines.
- Serve as a liaison within internal departments at with CROs and with regulatory program managers at HAs.
- Maintain regulatory files in a format consistent with internal requirements.
- Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance