- AbbVie (Lake Bluff, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs, Strategic Global Labeling - Combination Products ... terminology, guidelines, standards, etc. + Experience developing and implementing successful global regulatory labeling strategies. + Experience with… 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… 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 ... global needs as required. The RA Associate Director , Labeling will be overall responsible for...global strategies and local regulations . Coordinate US labeling activities for regulatory submissions, product maintenance… 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 for ... regulatory requirements. You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory … more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us This position will provide oversight of a team of Global Labeling Strategists responsible for driving labeling strategy ... and maintenance of global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities include, but are not… more
- Kelly Services (Gaithersburg, MD)
- … regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/ Global Regulatory Execution ... * Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs. * Leads the development of the labelling strategy,… more
- Amgen (Washington, DC)
- …It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology** **Live** **What you will do** ... Affairs Senior Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership,… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling - Remote Opportunity Requisition ID: 5211 Location: Deerfield, Illinois, US Do you want to join a team ... candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global ... affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and… more
- AbbVie (Boston, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead, is responsible for developing and ... and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
- J&J Family of Companies (Trenton, NJ)
- Director , Global Regulatory Leader (GRL) (1...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...they are doing in early/late development and knowledge of labeling aspects + Impact and Influence: Able to persuade,… more
- Sanofi Group (Cambridge, MA)
- …advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... About the Role The Associate Director , US Regulatory Affairs (RA) serves...Consults with senior management and provides input to the global organization as needed. + Contributes US RA AdPromo… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning ... + Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. + Develops solutions… more
- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to...and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of… more
- BeiGene (San Mateo, CA)
- **General Description** + The Senior Director , Global Regulatory Lead will be responsible for developing, implementing, and advising on global ... of department policies. **Responsibilities** + Uses extensive knowledge of global regulatory environment and the ability to...and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of… more
- BeiGene (San Mateo, CA)
- **General** **Description** **_:_** **The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising ... approvals of product and labeling changes.** **Maintains awareness of global regulatory environment and assesses impact of changes on business and product… more
- Bristol Myers Squibb (Madison, NJ)
- …Summary:** The Director , Development & Operations Lead (DevOps Lead) - Global Regulatory Sciences is accountable for leading the technical engineering, ... operations, and technical architecture teams in support of all Global Regulatory Sciences IT (GRS IT) Product...Regulatory Sciences (GRS) organization and impacted adjacencies. The Director will work closely with leaders across the GRS… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …consistency with product labeling and with all applicable regulations. TheSenior Director , Commercial Regulatory Affairs will stay abreast of changes in the ... and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for... global /US/Canadian regulatory framework, analyze proposed legislation/guidance that… more
- Bausch Health (Bridgewater, NJ)
- …in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Director is responsible for ensuring the pieces are ... Bausch Health is a global company that develops, manufactures, and markets a...Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations… more
- Bausch Health (Bridgewater, NJ)
- …reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. **KEY ... Bausch Health is a global company that develops, manufactures, and markets a...enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert… more
- Teva Pharmaceuticals (West Chester, PA)
- … submissions to major market health authorities as well as coordinate with global regulatory colleagues to prepare dossiers for global registration. ... Senior Director , Regulatory Affairs CMC , Innovative...Stock Purchase Plan, and Tuition Assistance **Reports To** VP, Global Regulatory Affairs **Already Working @TEVA?** If… more