- Chiesi (Cary, NC)
- … affairs, FDA regulations, or drug development. + Familiarity with FDA regulatory pathways (eg, IND, NDA, BLA, orphan drug designation). + ... FDA information requests). + Conducting background research on FDA regulations, guidance, and regulatory precedents relevant...of fall 2026 or later. + Strong interest in regulatory affairs and drug development, particularly within… more
- Medtronic (Minneapolis, MN)
- …dynamic and fast-paced environment. This position reports to the Senior Program Manager- FDA /Life Sciences, Enterprise Legal Regulatory . This will be an onsite ... **A Day in the Life** Medtronic is seeking an FDA /Life Sciences paralegal as a member of the Enterprise...Sciences paralegal as a member of the Enterprise Legal Regulatory (ELR) team with knowledge and experience navigating requirements… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, drug safety, market research, ... This position with the Regeneron Regulatory and Commercial Law team will provide proactive...to multiple internal stakeholders, including the commercial, medical affairs, regulatory , HEOR, corporate affairs, and compliance teams. Counsel will… more
- WuXi AppTec (Middletown, DE)
- … Compliance * Ensure all analytical testing meets FDA , EMA, and ICH regulatory requirements for drug product QC. * Maintain compliance with data integrity ... Strong understanding of ICH, USP, EP, JP, FDA , and EMA regulatory requirements for drug product QC. * Demonstrated ability to manage teams in a fast-paced… more
- WuXi AppTec (Middletown, DE)
- … Compliance * Ensure all analytical testing meets FDA , EMA, and ICH regulatory requirements for drug product QC. * Maintain compliance with data integrity ... USP <61>, <62>, <85>, <1116>, EP, JP, FDA , and EMA regulatory requirements for drug product QC. * Demonstrated ability to manage teams in a fast-paced… more
- Cardinal Health (Helena, MT)
- …Biotech and Medical Device/Medical Diagnostics with success + Experience selling consulting, drug development, regulatory services preferred + Highly organized + ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- University of Pennsylvania (Philadelphia, PA)
- …Regulatory Affairs Specialist C will, independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. ... and contribute to the development/maintenance of study-specific case report forms for FDA reporting, as well as provide direct regulatory /compliance guidance.… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …guidance for changes to an approved (A)NDA + Write domestic device and drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes ... or more program(s), including participation in external Food and Drug Administration ( FDA ) meetings, internal core team...proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA … more
- CVS Health (Annapolis Junction, MD)
- …to address them + Communicate and educate staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, ... and compliance developments (eg, state Board of Pharmacy, DEA, FDA , etc.) for pending regulatory changes and...physician to receive hard copy of prescription and perform drug recall surveillance and reporting In this role, you… more
- Ascendis Pharma (Princeton, NJ)
- …combination products. + Experience managing major regulatory filing(s) to the FDA Office of Prescription Drug Promotion (eg, launch advisory comment ... guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Regulatory Affairs,...and/or disease education communications + Serve as the company's regulatory liaison to the FDA 's Advertising and… more