- Bristol Myers Squibb (Princeton, NJ)
- …database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development, ... participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director , Biologics will serve as the primary… more
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing , legal, and medical teams to ensure that promotional practices are consistent… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... topics. **Responsibilities** - Supports CMC regulatory compliance activities for portfolio biologics to meet US, International Conference on Harmonization (ICH), and… more
- Takeda Pharmaceuticals (Columbus, OH)
- …to the best of my knowledge. **Job Description** **About the role:** ** Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology ... you will be a vital contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory Writing and Systems (NRWS) Department… more
- Regeneron Pharmaceuticals (Troy, NY)
- …DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics . + Lead and facilitate interactions ... with global regulatory authorities (eg, meetings, IR responses, inspections). + Perform final review and approval of the compliance activities of the portfolio to confirm regulatory impact and associated submission requirements for clinical and commercial… more
- Boehringer Ingelheim (St. Joseph, MO)
- …Ingelheim's high regard for our employees. **Group Leader, Antigen Production** Assist Associate Director / Manager in all phases of Antigen Production. ... position is to provide administrative and technical direction in Biologics Production according to company policies and corporate business...combinations. + Acts as a back up (deputy) to Associate Director , Antigen Production. + Establish and… more
- Grifols Shared Services North America, Inc (Little Rock, AR)
- …- Arkansas + The SSR-Pulmonology will report directly to a Regional Sales Director + This individual will be responsible for detailing the following customers: ... their territory + This person will execute on the National sales and marketing strategy and create a territory business tactical plan to maximize opportunity. This… more