- Gilead Sciences, Inc. (Foster City, CA)
- …guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and leads global ... system. **Qualifications** + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant industry experience or 10 + years… more
- Bausch Health (Bridgewater, NJ)
- …CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to deliver high… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual ... in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing innovative global ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be ... IND/NDA development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in developing and executing regulatory… more
- Danaher Corporation (Boston, MA)
- …compliance, driving innovation and excellence in the Biopharma sector. This position reports to the Director , Regulatory Affairs and is part of the Global ... m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory… more
- Ascendis Pharma (Princeton, NJ)
- …of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs , Advertising and Promotion. There is a preference for this ... to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will be an internal expert on… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Chiesi (Cary, NC)
- …+ Promotional Material/External Communications Responsibilities: + Heads Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... Standard Operating Procedures for related activities and provide training to Regulatory Affairs and other departments as appropriate. + Review and provide input… more