- Adecco US, Inc. (Morristown, NJ)
- Adecco Healthcare & Life Sciences is seeking a skilled ** CMC Regulatory Technical Writer II** to support a global pharmaceutical client in lifecycle management ... relevant experience level **Key Responsibilities:** + Author and develop CMC sections of regulatory dossiers (Modules 2 and 3) for development and post-approval… more
- Sanofi Group (Morristown, NJ)
- …in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation ... **Job Title:** Regulatory Strategist **Location** : Cambridge MA/ Morristown, NJ...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more
- Parexel (Trenton, NJ)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... TJC, OSHA. 5. Maintains clear, real time communications shift-to-shift and with leadership regarding issues, concerns and problems which may affect patient care or the operation of the department. 6. Participates in planning and implementing change through… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs, CMC , Biostatistics, GCO, in the execution of ... Lead, Clinical Scientist. and other functional areas such as GCO, biostats, regulatory , pharmacovigilance. The Director will be a key contributor to INDs, NDAs,… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director, Global Regulatory Strategy, Neuroscience** + Will be a key member of the GRSP ... Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. + Acts… more
- Parexel (Trenton, NJ)
- 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...in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are you ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more