- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Regulatory Project Management, GI 2 within our ... Global Regulatory Teams (GRTs) to ensure global regulatory project plans for...TRAVEL** + Remote within the US + Travel: The Director is expected to come to Quarterly GRA meetings… more
- Merck (Rahway, NJ)
- …for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist /...but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC… more
- Novo Nordisk (Princeton, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director , Global Regulatory Portfolio Lead. Essential Functions + ... The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work...Serve as a member of the Global Project Team (GPT) utilizing precedent and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... meetings globally. Responsible for representing GRA in the GPT ( Global Project Team) as well representing the... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT… 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
- Novo Nordisk (Plainsboro, NJ)
- …make a difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to...Essential Functions + Serve as a member of the Global Project Team (GPT) utilizing precedent and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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...position may serve as an ad hoc member of Global Project Team (GPT) to address labeling… more
- Ascendis Pharma (Princeton, NJ)
- …Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . Provide ... The Regulatory Affairs (RA) Associate Director , Labeling...for the United States and the Americas and supporting global needs as required. The RA Associate Director… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development and ... primarily to marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs, in collaboration with Head, Regulatory … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... to benefit from our therapeutics. **Responsibilities:** - Leads CDx project teams for the diagnostic, in full alignment with... teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all… more
- Cardinal Health (Trenton, NJ)
- … experts who provide consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs ... brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Sanofi Group (Bridgewater, NJ)
- …with Sanofi standardized methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment ... post-marketing activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
- Sanofi Group (Bridgewater, NJ)
- …with Sanofi standardized methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment ... activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, ... side) + **CDx RA Policy and Intelligence:** Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …breakthrough therapy designation requests, orphan drug applications. + Participate in global project team meetings (development and/or marketed products); ... and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure… more
- Sanofi Group (Bridgewater, NJ)
- …in regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively with ... impact on the environment advise internal stakeholders on evolving regulatory policy issues, and more! The Director ... intelligence reports or deliverables as it relates to project or process strategies to further regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner ... or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance...concepts, messaging, and campaigns. + Represents RA Ad/Promo at Regulatory Project Team meetings. + Represents RA… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global IT Quality Compliance Date: Apr 26, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 54945 ... make a difference with. **The opportunity** This role is part of the global Quality Compliance leadership team guiding CSV Quality Compliance within Teva. Within… more