- Cepheid (Miami, FL)
- …local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic ... manner with effective corrective action. Participate in external audit management (eg FDA , ISO, Danaher Corporate, foreign governments), in either a supporting or… more
- Bayer (NJ)
- …YOU ARE** Bayer seeks an incumbent who possesses the following: **Required Qualifications:** + US FDA regulatory experience in related drug or device area; + ... fast, resource efficient submissions of high-quality dossiers, driving Food and Drug Administration ( FDA ) communications and negotiations to achieve timely… more
- Boehringer Ingelheim (Ridgefield, CT)
- …associated with Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in ... areas of pharmaceutical law, one of which must be FDA Regulatory (eg, Transactions, FDA ...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Sanofi Group (Framingham, MA)
- …and roll-out of the Sanofi Quality Management System in line with US FDA cGMP regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi ... **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job...secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity,… more
- Cardinal Health (Phoenix, AZ)
- …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
- CVS Health (Henderson, KY)
- …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
- BeOne Medicines (San Mateo, CA)
- …negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to...in the oncology therapeutic area. + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… more
- Houston Methodist (Houston, TX)
- …developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the ... study team and sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the US FDA and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health ... to function as the lead interface with the US FDA and support regional and local regulatory ...Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory… more
- System One (Plainsboro, NJ)
- …Specialist is also responsible for maintaining product and establishment registrations ( drug /establishment listings) and submission to FDA databases. This ... Job Title: Regulatory Labeling Specialist Compensation: $95000 - $110000 annually...individual collaborates cross-functionally and applies skills and knowledge of drug development and how it relates to labeling operations… more
- IQVIA (Wayne, PA)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... and consortia + Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the… more
- Globus Medical, Inc. (Audubon, PA)
- …clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This ... position entails development of FDA submissions, requires working knowledge of products under review...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- Charles River Laboratories (Wilmington, MA)
- …supporting GMP activities while ensuring compliance with all appropriate worldwide governmental regulatory agencies ( FDA , EMA, HPRA, etc.) and corporate policies ... appropriate. ⦁ Serve as the coordination contact for governmental regulatory agencies (ie FDA , HPRA, EMA and...of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Affairs, Precision Medicine, you will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory ... You will provide fit-for-purpose operational and technical diagnostics (Dx) regulatory assistance through all stages of drug ...diagnostics used in therapeutic trials with global and local regulatory requirements (such as US FDA and… more
- Boehringer Ingelheim (St. Joseph, MO)
- …linking regulatory affairs information to internal and external stakeholders ( FDA ) to ensure sufficient and efficient communication through activities such as ... governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory ...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Medtronic (Minneapolis, MN)
- …develop solutions to complex US promotional issues. + Interact directly with FDA and/or indirectly with international regulatory agencies on most ... teams. + Provide feedback and on-going support to product development teams for regulatory issues and questions. + Prepare FDA , European and Canada submissions… more
- Fortive Corporation (Irvine, CA)
- …to regulatory affairs management in order to facilitate compliance with all FDA and other US and international regulatory requirements throughout the product ... regulations and interpretations. + Writes, coordinates, compiles, and submits Regulatory documents to FDA and other ...CFR 800-1299) + Proper application of US Federal Food, Drug , and Cosmetic Act (FD&C) Section 510(k) + Proper… more
- Abbott (St. Paul, MN)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve… more
- Takeda Pharmaceuticals (Boston, MA)
- … submissions. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. ... bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global … more
- Corning Incorporated (Tewksbury, MA)
- …Current understanding of FDA and rest of world compliance trends in Regulatory Affairs as relates to biological products, medical device, IVDs etc. + Maintain ... Regulatory Affairs Specialist, Biologics **Date:** Jun 11, 2025...increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields… more
