- System One (Florham Park, NJ)
- …Overview: This role will support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission ... of nonclinical, clinical, CMC, DMF, and labeling/SPL submission documents. + Familiar with regulatory guidelines, such as FDA , EMA, MHRA, and Health Canada.… more
- Meta (Burlingame, CA)
- …wrist wearables, and other innovative devices. **Required Skills:** Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or ... **Summary:** We're seeking a regulatory affairs specialist to join our medical devices...vigilance reporting, product recalls, etc., as needed 3. Prepare FDA , European and Canada submissions for product changes as… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and International ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Takeda Pharmaceuticals (Boston, MA)
- …plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including ... submissions and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global drug development… more
- Danaher Corporation (Boston, MA)
- …and alignment across global and culturally diverse stakeholders. + Experience with drug development and drug regulatory procedures. Leica Biosystems, ... a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion...of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device… more
- Merck (Rahway, NJ)
- …will also coach their staff in the concepts, methods, and nuances of, drug development, project management, and regulatory operations. + Operates well in ... experience in pharmaceutical/healthcare/consumer care industry + Leading cross-functional teams in regulatory affairs or other drug development functions +… more
- Charles River Laboratories (Wayne, PA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in… more
- ProMedica Health System (Toledo, OH)
- …Medication Safety Committee, coordinating RCAs, and implementing strategies to reduce adverse drug events (ADEs). * Regulatory Compliance: Ensures adherence to ... RELATIONSHIPS/SUPERVISORY RESPONSIBILITIES The Director of Medication Safety, Quality, and Regulatory Compliance will supervise system-wide initiatives for medication safety,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or other biologic products. + Experience leading development and execution of regulatory submissions of promotional materials for prescription drug or biologic ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within… more
- Takeda Pharmaceuticals (Boston, MA)
- …meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and ... post-market support. + Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams. + Able to deal… more
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