- 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 ... + 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 (Lake Bluff, IL)
- …on 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
- 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 ... of global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities include, but are not limited to:**… 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 (Palo Alto, CA)
- …the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with US ... The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for...labeling processes and infrastructure . Work closely with global labeling managers to ensure consistency and… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Legal Director (FDA promotion/ Labeling Drugs & Vaccines)** The position provides legal support to the Human ... counseling clients in the areas of FDA promotion and labeling of drugs and vaccines. The position also provides...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… 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
- Amgen (Washington, DC)
- …worldwide. It's time for a career you can be proud of. **Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology** **Live** **What you will do** ... Senior Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and… 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 where ... - Open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling, oversees the process… more
- AbbVie (Boston, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead, is responsible for developing and ... TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling ...of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
- J&J Family of Companies (Raritan, NJ)
- Senior Director , Global Regulatory Leader, CAR-T Therapy - 2406186120W **Description** Johnson & Johnson is currently seeking a Senior Director , Global ... have a positive impact on their communities. The Senior Director , Global Regulatory Leader, CAR-T Therapy will...including but not limited to the Compound Development Team, Global Dossier Team, Clinical Team, and the Labeling… 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
- J&J Family of Companies (Trenton, 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
- 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
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Pipeline Head for Neuroscience, Global Health Economics, Value, and Outcomes Date: Apr 15, 2024 Location: Parsippany, United States, New Jersey, ... Parsippany, New Jersey** The goals and objectives of the Global Health Economics, Value, and Outcomes department is to...world data studies, surveys, and economic models. The **Senior Director , Pipeline Head for Neuroscience** , will develop the… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Pipeline Head for Immunology, Global Health Economics, Value, and Outcomes Date: Apr 15, 2024 Location: Parsippany, United States, New Jersey, ... Parsippany, New Jersey** The goals and objectives of the Global Health Economics, Value, and Outcomes department is to...world data studies, surveys, and economic models. The **Senior Director , Pipeline Head for Immunology** , will develop the… more
- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory ... regulatory issues and to expedite approvals of product and labeling changes. + Maintains awareness of global ...and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of changes on… more
- Amgen (Los Angeles, CA)
- …science that can turn the tide of serious, life-interrupting illnesses. **Executive Director , Global Development Lead- Xaluritamig** **Live** **What you will ... and responses as well as: + Key regulatory/safety deliverables (eg, core labeling and global regulatory submission documents, periodic safety update reports)… more
- BeiGene (San Mateo, CA)
- **General Description** + The Senior Director , Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory ... regulatory issues and to expedite approvals of product and labeling changes. + Maintains awareness of global ...and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of changes on… more
- BeiGene (San Mateo, CA)
- **General** **Description** **_:_** **The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on ... of key regulatory issues and to expedite approvals of product and labeling changes.** **Maintains awareness of global regulatory environment and assesses… more