- Randstad US (Fort Worth, TX)
- associate director of regulatory operations - labeling . + fort worth , texas + posted july 12, 2024 **job details** summary + $60 - $71.43 per hour + ... lives, we have the ideal position for you! Position Overview: The Associate Director of Regulatory Operations - Labeling will lead and oversee the strategic… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs, Strategic Labeling is responsible for ... staff for assigned therapeutic area(s). Responsibilities + Develops and directs regulatory labeling strategy planning for or across assigned product group… 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 ... and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for...will be overall responsible for ensuring compliance with US regulatory requirements for labeling , and for coordinating… 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)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the ... 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)
- …Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling ... Associate Director , RA Labeling Product Leader (1...regulatory guidelines and their applications for guidance for labeling . + Experience leading project teams within a matrix… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and… more
- Merck (North Wales, PA)
- …review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and ... **Job Description** Reports to the Director /Senior Director in the Office of...standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to… more
- Bausch Health (Bridgewater, NJ)
- …reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. ... to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director , ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be responsible for...critical review of submission documents to ensure compliance with regulatory requirements. + Participates in development of labeling… more
- J&J Family of Companies (Titusville, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2)...and OUS markets. + Serve as a member of the Labeling Working Group to create or update the CCDS and ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of...they are doing in early/late development and knowledge of labeling aspects + Impact and Influence: Able to persuade,… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory ... Team_ + Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface… more
- Post Holdings Inc. (Hopkins, MN)
- …or outdoor lunch before, within, or after your work day. Responsibilities The Director of Regulatory Affairs and Customer Compliance is responsible for ... overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain. The position must effectively… more
- J&J Family of Companies (Columbus, OH)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...Strategy Plan) through active participation at relevant meetings (eg, Labeling Working Group, Regulatory Strategy meetings, Functional… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our ... Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is...preclinical, clinical and manufacturing charges. + Review and approve labeling to ensure compliance. + Represent regulatory … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...+ With support of Commercial RA, develops initial product labeling and assesses proposed product claim proposal (pre-NDA). +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …. Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications ... + Review and approval of promotional communications for conformance to product labeling and regulations related to Rx drug promotion. Reviews reflect appropriate… more
- AbbVie (Irvine, CA)
- …will be added to our talent pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory ... and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy Team (LRST), and serve as the primary regulatory interface… more
- Takeda Pharmaceuticals (Lexington, MA)
- …true to the best of my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review out of our Lexington, MA ... and regulations for development of marketing materials, including representation on global regulatory and labeling teams. + Provide leadership related to issues… more