What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at BioPhase?
- Temporary Senior Regulatory Clinical Science Specialist
- Covering for a maternity leave – position will last until October
- Full-time, on-site position - Summit, NJ
Position Summary:
The Temporary Senior Regulatory Clinical Science Specialist will report to the Director of Regulatory Clinical Science. This role is responsible for supporting the development of global clinical regulatory strategies for both investigational and marketed products, as well as assisting with the preparation of eCTD-formatted dossiers. The position requires a high level of expertise to ensure clinical trials are conducted in compliance with Health Authority regulations.
Essential Functions:
- Draft key BLA documents, including ISS, ISE, CSRs, labeling, and Module 2.5, along with cataloging and reconciling appendices.
- Review, edit, and approve final submissions in DocuBridge.
- Support daily operations beyond BLA submissions, such as protocol reviews/amendments, providing regulatory input on day-to-day issues, and supplying regulatory documents to other departments.
- Review clinical data, reports, and summaries to ensure adherence to protocols, statistical analysis plans, monitoring guidelines, and data management plans.
- Compile and report clinical study results from internal teams or CROs.
- Draft written summaries for regulatory submissions, including INDs, NDAs, and BLAs.
- Prepare or review essential documents such as investigator brochures, pharmacy manuals, protocols, clinical study reports, annual reports, DSURs, and clinicaltrials.gov entries.
- Provide training and support for others in preparing, analyzing, and documenting clinical studies.
Education & Experience:
- Bachelor’s degree in life sciences or a related field with 7 years of relevant regulatory clinical science experience required.
- OR Master’s degree in life sciences or a related field with 5 years of relevant regulatory clinical science experience required.
- Mid-level expertise in regulatory or clinical operations is preferred.
- Experience preparing clinical modules for eCTD submissions is highly desirable.
- Familiarity with organizing responses to Health Authority information requests is preferred.
- Knowledge of international regulatory submissions is a plus.
Salary : $55 - $70
