- Takeda Pharmaceuticals (Columbus, OH)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be ... + Lead cross functional teams to develop and update CCDS and other key global labeling documents (ie CCDS Working Team) + In coordination with Global … more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs, Strategic Global Labeling , combines the ... Product Characteristics (EU SPCs) and other Global Labeling . Under the direction of the Director ...labeling environment. + Under the direction of the Director , Global Labeling , provides regulatory… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs, Strategic Global Labeling - Combination ... documentation for healthcare providers and end user. Under the Director of Strategic Labeling , they establish combination...submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external ... Responsibilities + Acts as point of contact for cross-functional teams on global labeling issues. Based on timelines or resources, may assist another Global… more
- Ascendis Pharma (Princeton, NJ)
- …States and the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance ... The Regulatory Affairs (RA) Associate Director , Labeling will...labeling processes and infrastructure . Work closely with global labeling managers to ensure consistency and… more
- Gilead Sciences, Inc. (Boston, MA)
- …and career interests. Position will be filled as a Senior Manager or Associate Director , based on candidate experience. **REQUIREMENTS:** We are all different, ... create possible, together. **Job Description** Job Description Regulatory Affairs Labeling is a core function within Gilead's Global... Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical… more
- Kelly Services (Gaithersburg, MD)
- Description: The Labelling Strategy Associate Director provides regulatory labelling expertise, typically for more complex drug projects, to the Global ... including risk insight and proposing mitigations * Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare ... and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand… 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 ... to Commercial teams during the development, review and approval of product labeling and advertising materials. + Work directly with Commercial teams from concept… 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 ... regulations, corporate standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for… more
- Bausch Health (Philadelphia, PA)
- …mission of improving people's lives with our health care products. he Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, ... Bausch Health is a global company that develops, manufactures, and markets a...approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. **KEY… 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 ... we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other....on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the… more
- CSL Behring (King Of Prussia, PA)
- The Opportunity: The Clinical Trial Supply (CTS) Asset/Program Lead ( Associate Director ) is an experienced clinical supply chain professional accountable for the ... and Clinical Development Teams, as well as with Commercial, Operations and Global Supply Planning. 2. Influences protocol design and leverages concepts like pooling,… more
- Boehringer Ingelheim (St. Joseph, MO)
- …programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/ Associate Director , Regulatory Affairs Pharma Safety & Efficacy you will: ... BI. + Ability to handle high workloads and understanding of cultural differences. ** Associate Director - Additional Requirements** + Advanced degree (Doctor of… 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 ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...individuals. + Provides guidance on development and review of labeling and promotional material for compliance with regulations; works… more
- Sanofi Group (Bridgewater, NJ)
- …support the Diabetes Franchise business, driving the growth of the General Medicines Global Business Unit. In our team, you will manage the US post-marketing ... post-marketing activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the...Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for… more
- Sanofi Group (Bridgewater, NJ)
- …+ Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead ... regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution...Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for… more
- Merck (Boston, MA)
- **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our ... portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The… more
- Bristol Myers Squibb (Princeton, NJ)
- …and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. **Position Summary** Leads Safety Data Review (SDR) ... with limited or no oversight. + Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related… more