What are the responsibilities and job description for the Regulatory Affairs Specialist position at WhiteCap Search?
Our client, a growing biopharma company, is seeking a Regulatory Affairs Specialist to support regulatory strategy and submission activities as the company advances its pipeline through clinical development.
Key Responsibilities
Key Responsibilities
- Support preparation, compilation, and submission of regulatory documents (INDs, amendments, annual reports, briefing packages) to FDA and/or other health authorities
- Track and maintain regulatory submission timelines and correspondence logs
- Coordinate cross-functional input (clinical, CMC, nonclinical, quality) for submission-ready documents
- Monitor changes in regulatory guidance and assess impact on ongoing programs
- Support preparation for regulatory agency meetings, including briefing document development
- Maintain regulatory files and ensure inspection/audit readiness
- Assist with labeling review and other regulatory deliverables as programs progress
- Bachelor's degree in life sciences, regulatory affairs, or related field; RAC certification a plus
- 3 years of regulatory affairs experience in pharma or biotech, with hands-on submission experience
- Working knowledge of FDA regulations and ICH guidelines; global submission experience a plus
- Strong writing, organizational, and project management skills
- Experience using regulatory information management (RIM) systems and eCTD publishing tools a plus
- Comfortable working independently and adapting to shifting priorities in a smaller, fast-moving organization
Location/Region: Cambridge, MA