- Insight Global (Mount Laurel, NJ)
- Job Description Insight Global is seeking a Regulatory Remediation Specialist for a full-time opportunity with a large Banking client. This person will work out ... Ft. Lauderdale, FL office. In this role, this Specialist will perform Regulatory Assurance and Quality Control reviews of US technology remediation activities. They… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and ... stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for… more
- Chemours (Trenton, NJ)
- …internal processes with a focus on medical application reviews. + Support global product stewardship, regulatory and sustainability teams including product ... depend on Chemours chemistry. Chemours is seeking a Product Stewardship & Regulatory Expert - Medical Applications to join our growing Advanced Performance Materials… more
- Sanofi Group (Morristown, NJ)
- …Artwork & ePI, this role is responsible for designing and driving the global Artwork program roadmap, coordinating regulatory alignment across regions, and ... for defining and implementing the long-term strategic roadmap for Sanofi's global Artwork transformation, ensuring regulatory excellence, digital innovation, and… more
- Organon & Co. (Jersey City, NJ)
- …updates to labeling tracking reports and databases, and provides status updates to Global Labeling management. + Provides regulatory expertise and guidance for ... labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and most of… more
- Sanofi Group (Morristown, NJ)
- …with all key stakeholder in GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the ... ** Global Project Head -AATD* SAR447537** **Development** The ...GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label,… more
- Sanofi Group (Morristown, NJ)
- …diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within ... Global Research and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800 people. The GRA Device Lead for Specialty… more
- Insight Global (Summit, NJ)
- Job Description Insight Global is looking for a CMC Regulatory Consultant to join the Regulatory Affairs organization within R&D at a Consumer Healthcare ... organization. This individual will be responsible for authoring, reviewing, and approving regulatory documents and submissions within Module 2 and Module 3. They… more
- Sanofi Group (Morristown, NJ)
- …registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. + Participate in Change Control assessment. ... define the future submission strategy; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs. + Coordinate the submission of CMC … more
- Bristol Myers Squibb (Princeton, NJ)
- …labeling strategies. + Act as the key PV representative for interactions with global regulatory authorities and stakeholders, advocating for patient safety. + ... benefit-risk assessment, and aggregate safety reporting. + Experience interacting with global regulatory authorities and scientific advisory bodies **Preferred… more