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The candidate selected for this role will Provide legal guidance and counseling to business and functional teams (such as sales and marketing, regulatory affairs, medical affairs, government affairs, patient access, clinical, quality, R&D, finance, and others). Proactively identify and manage regulatory legal risks for complex US or global issues and develop and approve a
Posted 17 days ago
Exelixis
- Alameda, CA / King of Prussia, PA
/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval, with a particular focus on biologics (ADCs, bispecifics, and etc.). Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines, as well as companion diagnostics, as appropriate. Provide
Posted 19 days ago
WEX, Inc.
- Portland, ME / San Francisco, CA / Washington, DC / 3 more...
About WEX Bank WEX Bank is a leading provider of financial solutions and payment services. We are committed to providing our customers with exceptional service while maintaining the highest standards of compliance and ethical conduct. About the Role We are seeking a highly experienced and skilled Regulatory Compliance Manager 3. The candidate who assumes this role will le
Posted 19 days ago
of the role Ardelyx is seeking a passionate individual who works with integrity and determination, to make a difference for patients. Reporting to the Vice President and Head of Global Patient Advocacy, the Director of Government Affairs will be responsible for leading and executing the Ardelyx government affairs strategy at the state and federal levels in close alignment
Posted 19 days ago
of the role We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Position Responsibilities Assist with the collection, coordination, and preparation of infor
Posted 20 days ago
Exelixis
- Alameda, CA / King of Prussia, PA
/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti
Posted 21 days ago
The Sr. Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical, Inc. (SWMI). The Sr. Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, ma
Posted 27 days ago
We provide our utility clients with a wide range of energy saving and renewable energy solutions. From individual utility customers and construction contractors, to utilities, municipalities, and government bodies, our clients have come to depend on our customized energy efficiency programs to help them to meet their energy saving goals. The Energy Advisor is primarily fo
Posted 28 days ago
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