- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- Drive Labeling Strategy , in-line with overall global regulatory strategy , by providing labeling expertise for Company Core Data Sheet (CCDS), USPI ... negotiation strategies. + Support global HA interaction strategy to discuss key labeling elements. +...facilitate final label negotiations and approval. + Present to Global Labeling Review Team: Ensure Core Data… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of end-to-end labeling processes and systems. **Job Description** + Act as Global Labeling Strategy Lead, supporting preparation, review, and update of ... to drive alignment of labeling content and strategy . + Partner with Global Regulatory Affairs...all labeling is aligned with the product global strategy and key messaging. + Evaluate… more
- Ascendis Pharma (Princeton, NJ)
- Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs ... Sciences team for the US business, the Associate Medical Director supports the US Medical Director for...and implementation of the product medical and medical launch strategy as well as working intricately within the other… more
- Sumitomo Pharma (Trenton, NJ)
- …for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based ... regulatory activities for assigned project(s) in line with the global registration strategy of the product +...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- GRAIL (Trenton, NJ)
- …North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, ... please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with...to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs… more
- Ascendis Pharma (Princeton, NJ)
- Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs ... Act; and implementing regulations promulgated by the FDA pertaining to drug labeling and the advertising and promotion of pharmaceutical products. + Draft, negotiate… more