- State of Michigan (Lansing, MI)
- Departmental Specialist 13 - FDA Retail Inspection Program Specialist Print (https://www.governmentjobs.com/careers/michigan/jobs/newprint/5138710) Apply ... Departmental Specialist 13 - FDA Retail Inspection Program Specialist Salary $2,559.20 - $3,820.00 Biweekly Location Lansing, MI Job Type Permanent Full Time Job… more
- General Dynamics Information Technology (Silver Spring, MD)
- …Analyst** for new contract to support the **Food and Drug Administration ( FDA )** and their critical mission needs. As a Business Requirements Analyst, you ... our clients. Current or past experience working at the FDA in a similar capacity is required.** **This is...at the GDIT office in Gaithersburg, MD and/or the FDA office in Silver Spring, MD.** **Responsibilities:** + Assists… more
- AbbVie (Washington, DC)
- …US Policy will monitor, track, and analyze key US Food and Drug Administration ( FDA ) public policy issues that could impact AbbVie and the patients we serve. The ... (USPA) team for all legislative and regulatory policy developments related to FDA . The Director will work with internal stakeholders to determine the impact… more
- CBRE (Indianapolis, IN)
- Quality & Compliance Specialist ( FDA Regulated Industry) Job ID 244368 Posted 22-Oct-2025 Service line GWS Segment Role type Full-time Areas of Interest Laboratory ... Services Location(s) Indianapolis - Indiana - United States of America Full Spectrum Lab Services from CBRE offers a professional suite of services to a variety of clients in the life sciences industry, including those in pharmaceuticals, biotech, medical… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- This position with the Regeneron Regulatory and Commercial Law team will provide proactive and collaborativeetc. **Salary Range (annually)** $238,400.00 - $397,300.00 ... legal advice and counsel in connection with the commercialization of one or more of Regeneron's products, and be part of a legal team supporting cardiovascular, hematology, rare disease, oncology, obesity, and new products. Counsel will be embedded as a core… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an ... candidate will need to be able to review and sign various submissions to FDA . It will include ANDA cover letter, Form 356H for Original ANDAs, Amendments to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …processes to prepare initial proposed draft labeling for submission to FDA ensuring appropriate supportive information is provided. **Requirements** + Bachelor's ... with a minimum of ten (10) years' experience in Regulatory Affairs, FDA , or equivalent experience in the regulated pharmaceutical industry (biologics or small… more
- University of Pennsylvania (Philadelphia, PA)
- …and governmental approval for clinical trials. These trials often include FDA -regulated products, including drugs, medical devices, nutritional products and related ... independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. Regulatory applications may include new… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …works directly for the Clinical Trials Office to complete and oversee FDA regulatory requirements specific to vaccine research or other critical DFCI-developed ... assigned INDs to ensure regulatory compliance with all Food and Drug Administration ( FDA ), National Institutes of Health Office of Special Projects (NIH OSP), and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the draft CCDS. + Provide US guidance to global team on FDA submissions, meetings, and pediatric development requirements including preparation of documentation, as ... if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External Partnerships: + Provide broad and… more
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