Category: Scientific & Clinical
Title: Regulatory Affairs Manager
Location: Bridgewater, NJ
- Bachelor’s Degree in related field or equivalent experience required; Advanced Degree preferred
- Minimum of 5 years or related experience, including at least 3 years experience in US Regulatory Affairs (Clinical Regulatory Affairs)
- Prior experience with drug IND/NDA/ANDA preferred
- Prior experience interacting with the FDA
- Experience developing pland for submitting INDs
- Strong working knowledge of FDA guidance documents, CFR, GCPs, GMPs, and ICH
- Provide regulatory support for ongoing and planned clinical trials including the review of essential regulatory document, protocols, SAP etc.
- Plan, author and/or review documentation to ensure timely submission of product annual reports and related DMFs for assigned programs.
- Support the development of regulatory strategies to provide internal guidance for business partners and management.
- Provide authoring and/or review of technical and scientific documentation for inclusion in INDs, NDAs, ANDAs, amendments and supplements accordingly.
- Evaluate new scientific literature, guidance documents, and regulations that may impact assigned projects or the company.
- Liaise with internal colleagues, outside vendors/contractors and FDA and other government agencies regarding development product activities and/or submissions and amendments.
- Prepare meeting/briefing package documents for FDA meetings and ensure management and pertinent team members are well prepared prior to FDA meetings.
- Prepare draft responses and amendments to IND, NDA, and ANDA submission inquiries.
- Attend meetings as the regulatory representative when required to support developmental or commercial activities.
- Perform any other tasks/duties as assigned by management.