- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare 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 position may serve as an ad hoc member of… more
- Merck & Co. (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 ... review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Ascendis Pharma A/S (Palo Alto, CA)
- The Regulatory Affairs (RA) Associate Director , Labelling will be responsible for labelling activities across programs and stages of development, with ... will be overall responsible for ensuring compliance with US regulatory requirements for labeling , and for coordinating...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director , Regulatory Affairs Advertising and Promotion Locations: United States - California - Foster City Time Type: Full time Posted On: Vor 11 ... regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. Example Responsibilities: Provides commercial regulatory… more
- Avidity Biosciences (San Diego, CA)
- Job Title: Associate Director - Regulatory AffairsLocation: San Diego, CA / Hybrid / RemotePosition type: Full timeFLSA: ExemptDepartment: Regulatory ... visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.The OpportunityThe Associate Director , Regulatory Affairs is responsible for… more
- Ascendis Pharma (Palo Alto, CA)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... Americas and supporting global needs as required. The RA Associate Director , Labeling will be...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare 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 position may serve as an ad hoc member of… more
- Takeda Pharmaceuticals (Columbus, OH)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , RA Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling content… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** +… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...preclinical, clinical and manufacturing charges. + Review and approve labeling to ensure compliance. + Represent regulatory … 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 ... labeling . Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the best of my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review out of our Lexington, MA or ... and regulations for development of marketing materials, including representation on global regulatory and labeling teams. + Provide leadership related to issues… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New Product ... levels in one sensor. The role will also include responsibilities for regulatory support for on-market change management and manufacturing sites. The individual has… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... pharmaceutical products across therapeutic areas + Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life ... + Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities +...+ Provide strategic direction (and content input) on US Labeling + Anticipate and interpret key trends and changes… more
- Kelly Services (Alameda, CA)
- ** Associate Clinical Supplies Director ** Think the best job opportunities are far away? Think again. Great opportunities are right here in your backyard. ... Kelly(R) Science & Clinical is looking for an ** Associate Clinical Supplies Director ** to work at...for multiple programs and study levels. + Overseeing the labeling , packaging, release, distribution, and returns of clinical supplies… more
- J&J Family of Companies (Skillman, NJ)
- Senior Associate , Regulatory Affairs - 2407025090W **Description** Kenvue is currently recruiting for: Senior Associate , Regulatory Affairs, Dietary ... Supplements This position reports to the Director , Regulatory Affairs and is based in...**Pay: 84k- 152k** **What you will do** The Senior Associate , Regulatory Affairs is responsible for developing… 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
