- Helena Laboratories Corporation (Beaumont, TX)
- …preparation and work with and direct a small accounting team in a FDA regulatory and Union environment. Performs various clean-up and housekeeping duties. Observes ... and follows all safety rules and procedures, including wearing required PPE. Performs various other duties and activities as directed by the CFO. Must meet all elements of the Helena Standards Pertaining to All Jobs, Job Classification Standards - Job… more
- Medtronic (Minneapolis, MN)
- …connected, compassionate world. **A Day in the Life** Medtronic is seeking an FDA /Life Sciences paralegal as a member of the Enterprise Legal Regulatory (ELR) team ... environment. This position reports to the Senior Program Manager- FDA /Life Sciences, Enterprise Legal Regulatory. This will be an...years of experience **NICE TO HAVE:** + Experience with FDA and FTC advertising and promotion regulations + Medical… more
- Parexel (Nashville, TN)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to ... join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs… more
- DRT Strategies, Inc. (Arlington, VA)
- …qualification, and strategic capture of new business opportunities with the HHS/ FDA . This includes driving the end-to-end capture lifecycle: market research, ... process. + Demonstrable, hands-on success with business development for the FDA Preferred Experience: + Completion of government business development and capture… 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
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …strong background in pharmaceuticals to provide legal and regulatory support for FDA promotional review activities and research & development initiatives. This role ... entire legal group. Key Responsibilities: Promotional Review: + Advise on FDA regulations, guidance, and enforcement trends related to advertising and promotional… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Jarratt, VA)
- …the results associated with Sanitation KPI's, Internal & External Inspections (USDA, FDA , GFSI) and Customers Requirements. It is responsible for identifying food ... Food Safety, GFSI (BRC & SQF ) and Regulatory requirements (USDA and FDA ). This individual shall ensure the Sanitation Programs adoption and execution directly and… more
- Actalent (Colonie, NY)
- …the production of sterile injectable medications, ensuring full compliance with FDA 503B regulations, USP and guidelines, and company Standard Operating Procedures ... (cGMP), USP / standards, and facility SOPsjobtarget.com. Ensure all activities meet FDA 503B outsourcing facility requirements and the Drug Quality and Security Act… more
- System One (East Windsor, NJ)
- …for creating a QA system to notify the US Food and Drug Administration ( FDA ) of illegitimate products, as and when needed. + This position will also review ... guidelines for creating a QA system to notify the FDA of illegitimate products, as and when needed. +...gather the required data and information to notify the FDA of illegitimate products. + Assist the Associate Manager… more
- Sumitomo Pharma (Montgomery, AL)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. ... Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion… more
