- J&J Family of Companies (Horsham, PA)
- Associate Director , Global Labeling Product Leader - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... + Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI)… more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible ... international standards and guidelines. You will provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... States and the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Sanofi Group (Cambridge, MA)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Associate Director , US Advertising and Promotion serves...AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Associate Director , US Advertising and Promotion serves...review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. + Develop solutions to complex… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the...Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials. +… more
- Bristol Myers Squibb (Trenton, NJ)
- … of US Medical Oncology, Genitourinary (GU). The primary responsibility of this Associate Director is conducting strategic review of promotional materials and ... and objectives with the GU tumor portfolio. As a promotional review lead, this Associate Director role is a strategic partner who is solution oriented and… more
- Lilly (IN)
- …South San Francisco, Stamford, CT, and Madrid, Spain. **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for the end ... supply plans including drug supply forecasts for manufacturing, packaging, and labeling operations. + Provide technical oversight of packaging and distribution… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Persons with a non-science degree having relevant professional experience may be considered. + Associate Director level: must have three to five (3-5) years of ... with Food Drug Cosmetic Act (FDCA) and for consistency with product labeling . Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work on-site at ... CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of… more
- BeiGene (Emeryville, CA)
- **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... in departmental activities **Supervisory Responsibilities:** This position has no direct reports. The Associate Director , Safety Scientist is part of a team that… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions + Provide… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** ** Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory Affairs ... Headquarters Associate Principal Scientist supports products in the Vaccine and...as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling , Regulatory Chemistry, Manufacturing and Control (CMC) as well… more
- University of Rochester (Rochester, NY)
- …Unity (CMSU), consisting of approximately 15 team members, with two Directors ( Director Operations and Director Quality Assurance) and the clinical trials ... licensing requirements, and professional standards pertaining to secondary packaging, labeling , blinding, distribution and return services of clinical supplies… more
- Bristol Myers Squibb (Summit, NJ)
- …careers.bms.com/working-with-us . **Position Summary** Bristol Myers Squibb is seeking an Associate Director , Principal Product Leader within the Cell Therapy ... teams + Act as QA approver for product specifications and product labeling + Provides supportive quality oversight and guidance during product launch +… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs, you will be responsible for managing a team that develops and executes the strategy and ... supervision of individuals. + Provides guidance on development and review of labeling and promotional material for compliance with regulations; works closely with… more
- ThermoFisher Scientific (Wilmington, NC)
- …( eg PBRER, PSUR, DSUR) as well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS, RMP and CSR). **Essential Functions:** Manages ... 2 years). + Candidates with industry experience(CRO/Pharma) maybe considered for Medical Director /Senior Medical Director level. _In some cases an equivalency,… more
- Astellas Pharma (Northbrook, IL)
- …further consideration. + Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that contents of promotional and sales training ... in development. **Organizational Context:** Position will report to a Sr Director or Director of Promotion Review within US Regulatory Affairs. This individual… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related ... RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and… more