- 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 ... within Medical Writing. Furthermore, you have: + Experience in authoring clinical/ regulatory documents. + Excellent verbal and written communication skills with the… more
- Sanofi Group (Morristown, NJ)
- …could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global ... their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU, and/or… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …ongoing compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, interact ... product development and change control to ensure US, EU, and other global regulatory requirements are met. + Evaluates medical device regulations and leads… more
- Merck (Rahway, NJ)
- …communication and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the ... solutions to the global market. **Position Overview** The Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory… more
- Organon & Co. (Jersey City, NJ)
- …teams, along with alliance partners and commercial teams, in creating and implementing global regulatory CMC strategies for the registration, maintenance, and ... expansion of biosimilar products. + Lead the development and implementation of global regulatory strategies by assessing CMC changes, identifying regulatory… more
- Organon & Co. (Jersey City, NJ)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage ... unexpected events. He/she must have a depth of experience in defining global regulatory CMC strategies, superb collaboration skills, rapid, disciplined decision… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well ... or regions of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide… more
- Integra LifeSciences (Princeton, NJ)
- …(RIMS) to ensure data accuracy and process efficiency. A strong understanding of global regulatory requirements, both US and international, is essential, along ... data uploads and verification, and ensuring high-quality, timely support for the Global Regulatory Affairs function and broader organizational compliance at… more
- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing,… more