- CSL Behring (King Of Prussia, PA)
- …a hybrid position and is onsite three days a week. You will report to the Executive Director , Head, Global Labeling & Labeling Data Strategy. The ... a meaningful difference worldwide. Could you be our next Director , Global Advertising and Promotion? The job... oversight, leadership and direction to develop and execute global regulatory ad/promo strategies to support product… more
- BeOne Medicines (Emeryville, CA)
- …with applicable regulatory requirements and guidelines, and consistency with approved labeling . The role also is expected to work closely with our in-house ... the Labeling Working Group. + Serve as the lead regulatory representative on various cross-functional teams, including promotional and medical review committees.… more
- BeOne Medicines (San Mateo, CA)
- …expedite approvals of product and labeling changes + Maintains awareness of global regulatory environment and assess impact of changes on business and ... **General Description:** The Director , Regulatory Affairs will be responsible...line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our company ... portfolio of clinical trials.- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The… more
- Formation Bio (New York, NY)
- …on-board products with strong IP potential, and thereafter coordinate patent and regulatory activities to deliver best-in-class IP positions. We expect this person ... of use patents, lifecycle management strategies, process-related discoveries and labeling -related IP issues Oversee trademark, trade secret, and data exclusivity… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... from concept to implementation, ensuring that our packaging meets all regulatory requirements, protects product integrity, and enhances user experience. The… more
- Lundbeck (Deerfield, IL)
- …and KOL relationships and collaborating with other functions (eg, Value Evidence, Regulatory , Clinical Development, Brand Teams, Global Medical Affairs etc.) in ... Associate Director Medical Affairs - Neurology Requisition ID: 7013...including late stage and pipeline products + Collaborate with global Medical Affairs and cross-functional teams ( Regulatory ,… more
- Organon & Co. (Jersey City, NJ)
- …, Biopharmaceutics will be the primary author for module 2.7.1 for global regulatory submissions. **Responsibilities** + Provide support for the Biopharmaceutics ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of… more
- BeOne Medicines (Emeryville, CA)
- …+ Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Education Required:** + PharmD,… more
- Organon & Co. (Jersey City, NJ)
- …2.7.2 and contribute to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- CSL Behring (King Of Prussia, PA)
- …and clinical expert in the assigned disease area. + Provide input on US labeling and regulatory strategy. + Maintain in-depth understanding of disease states, ... **The Opportunity** As the Senior Director , Medical Affairs, you will lead the development...Develop and execute annual US Medical plans based on global Medical strategies + Localize global Medical… more
- Coty (Morris Plains, NJ)
- … global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is based in ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR MANAGER, US...retailers. + Provide guidance to Product Development regarding OTC labeling and claims. Including working with the global… more
- Endo International (Rochester, MI)
- …develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering ... everyone we serve live their best life. **Job Description Summary** The Director of Operations at the Rochester MI facility leads the establishment, implementation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will ... Stakeholder Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- J&J Family of Companies (Raritan, NJ)
- …a global or multinational setting. + Proven expertise in regulatory labeling , including content development, document management, translations, and digital ... your applications will be considered as a single submission. ** Director , Labeling Science and Technology Leader - Cross-Regional Regulatory Affairs** Are you… more
- Bristol Myers Squibb (Princeton, NJ)
- … Labeling is a senior leadership position responsible for shaping and executing global regulatory labeling strategies to support company objectives and ... documents for US, EU, and international markets. The Executive Director oversees labeling management, labeling ...content management. + Participates and drives Global Labeling Policy, partnering with Global Regulatory… more
- J&J Family of Companies (Raritan, NJ)
- …single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Labeling Product Leader. This position is a ... Raritan, NJ; Titusville, NJ; or Horsham, PA. The Associate Director , Global Labeling Product Leader...global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... Stakeholder Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
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