- ThermoFisher Scientific (Greenville, NC)
- …global labeling operations within a matrixed environment. + Acts as a labeling strategist within Global Regulatory Affairs (GRA), ensuring alignment of ... labeling **strategist and thought leader** within Global Regulatory Affairs . + Strong understanding of **...Regulatory Affairs . + Strong understanding of ** regulatory requirements** relevant to global drug development, labeling… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape. + Understanding of other relevant regional … more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ridgefield, CT location* For assigned development projects and US marketed products, the Director , US Product Group Regulatory Affairs will provide expert ... and represent US RA on US cross-functional teams. The Director , US Product Group Regulatory Affairs...including formal meetings, FDA review of registration packages, and labeling negotiations. + Establishes and implements US regulatory… more
- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety &...technical input for Freedom of Information Summary and product labeling for assigned projects. + Works in project teams… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and... impact of new campaign concepts, target, or product labeling , and providing strategic regulatory guidance on… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The ... role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply...and subpart E and H submissions + Ensure full regulatory compliance of all promotions with approved labeling… more
- BeOne Medicines (San Mateo, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline ... with applicable regulatory requirements and guidelines, and consistency with approved labeling . The role also is expected to work closely with our in-house… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. Director of Regulatory Affairs is responsible for developing and implementing ... Director , Regulatory Management, WW IPD ("Sr Director Regulatory WWIPD") and submissions, in support...with US and international laws and regulations + Manage Regulatory Affairs platform and leads a team… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Associate Director , Global Regulatory Affairs , you will act as the ... authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and...or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... conversion to OTC or OTC Monograph direct including any labeling reviews and updates. + Ensure all manufacturing, packaging,...industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be… more