- Eisai, Inc (Nutley, NJ)
- …governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to ... your profile, we want to hear from you. The Director , Global Labeling is responsible...of drug development processSolid working knowledge and experience of global regulatory labeling environments and… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global ...team leadership and motivation of staff to successfully execute global labeling regulatory strategies. + ... to candidates in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global ...direct the development of creative solutions to unusually complicated regulatory labeling and systems problems. + Ability… more
- GRAIL (Harrisburg, PA)
- … plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing ... North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate ... ready to make a difference? The Position The Medical Director serves as the subject matter expert for our...Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30%… more
- Insmed Incorporated (NJ)
- …, distribution, returns, reconciliation, destruction, and logistics for global clinical programsDefine and implement comprehensive sourcing strategies, engaging ... analytics), drive process optimization, resilience, sustainability, and operational excellenceOversee global depot inventory, labeling strategies, temperature excursion… more
- Insmed Incorporated (NJ)
- …company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management ... to regulatory authorities, health authorities, or at conventions, meetings, etc. Global Pharmacovigilance experience, including robust knowledge of global PV… 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
- 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
- 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)
- …, 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
- Endo International (Hobart, NY)
- …develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering ... Quality Assurance groups successfully issue and control labels and labeling confirming that issuance is on time and accurate....metrics for groups in conjunction with the Site Quality Director , and manages the performance to those goals. Ensures… more
- Revelyst (Irvine, CA)
- … laws and regulations. + Support product compliance team and legal submission of global mandatory reports to regulatory bodies when necessary. + Review marketing ... Golf and Foresight Sports. This position reports to the Director of Product Compliance and is based out of...manufacturing partners. + Staying aware of changes in the regulatory environment to minimize the impact to the business.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …practices and processes to Olympus and will report directly to the Medical Safety Director as a member of the global medical safety team. Additionally, you ... an integral role in the day-to-day functioning of the global medical safety organization. In this vital role you...well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care… 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
- 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
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …**Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice. + ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with ... related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , DRA Product Labeling will lead and manage the coordination ... labeling initiatives in compliance with Corporate and local regulatory requirements. The AD, DRA Product Labeling ...labeling section of NDA Annual Reports. **Requirements** Associate Director : + Bachelor's degree with a focus in Biology… more
- J&J Family of Companies (Spring House, PA)
- …https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Director , Global Regulatory Leader. This position is a ... We invite candidates from any location to apply. The Director , Global Regulatory Leader in...understanding of the competitive landscape (eg, views of HAs, regulatory precedents, labeling differences and disease area-specific… more
- AbbVie (Florham Park, NJ)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory Strategy is responsible for ... therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
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