- BeOne Medicines (San Mateo, CA)
- …affairs, legal, healthcare compliance and other business functions primarily in the United States with some activities globally to ensure compliance with ... **General Description:** This role is the head of Promotional Regulatory, and provides regulatory leadership, support, oversight, and strategic guidance on… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …to regulatory agency ( FDA /Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety ... regulatory inspection in US ( FDA regulatory agencies),participate in audits and...up. Establish the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + Review… more
- ThermoFisher Scientific (Mount Prospect, IL)
- …clinical packaging, labeling, and distribution operations. The Site Quality Head ensures that quality systems are successfully implemented, regulatory expectations ... This role is both strategic and hands-on, providing leadership across compliance , inspection readiness, continuous improvement, and client partnership. **A Day in… more
- Sanofi Group (Cambridge, MA)
- …are conducted in compliance with current regulations, laws, and guidance from FDA , EMeA, and CHMP, as well as with Sanofi's policies and procedures. **About ... **Job title:** Global Program Head , Neurology **Location:** Cambridge, MA **About the job**...they are required to perform. Including accountability and maintaining compliance training for direct reports + Works cross functionally… more
- Takeda Pharmaceuticals (Lexington, MA)
- …quality systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. + ... (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality standards. + Define and lead... with applicable medical device and software regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971,… more
- Abbott (Sylmar, CA)
- …Lead data generation, validation protocols, and submission strategies for new FDA 510(k) AI-based SaMD modules. Support international regulatory submissions. + ... high-impact AI innovation team; foster a culture of excellence, collaboration, and compliance . Coach and mentor team members on performance and development needs,… more
- L3Harris (Anaheim, CA)
- …CFR 163) as well as L3Harris policies and procedures. + Monitor and support compliance with FDA regulations for imports; Temporary Import under Bond shipments; ... program at two division locations (Orlando, FL and Hilton Head , SC). + Maintain, improve, and follow current published...Work cooperatively and proactively across functional areas to ensure compliance with all US export laws, rules… more
- Ascendis Pharma (Princeton, NJ)
- …fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States . Today, we're advancing programs in Endocrinology Rare ... for employees to grow and develop their skills. The Program Safety Lead reports to Head of Global Medical Safety Science. Under the direction of Head of GPS… more
- ThermoFisher Scientific (Carlsbad, CA)
- …Inc. **LOCATION:** 5781 Van Allen Way, Carlsbad, CA 92008 **TITLE:** Staff Specialist, Compliance **HOURS:** Monday to Friday, 8:00 am to 5:00 pm DUTIES: Ensure ... compliance with applicable local, state, federal, and international regulations...local, state, federal, and international regulations and standards (eg, FDA , ISO, GMP). Stay current with changes in regulatory… more
- Genentech (Oceanside, CA)
- …plant operations and manufacturing data. The candidate will report to the Site Head of IT/OT, an organization that is currently undergoing a transformation towards ... OT team you will have responsibilities for IT OT compliance and Validation ensure compliance for all...Represent ITOT in internal(SSI, GARA, quality etc.) and external audits( FDA etc.). + "Right to Operate" : Manage ITOT… more