- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Merck & Co. (Rahway, NJ)
- …review and final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory strategy to optimize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) ... research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides… more
- Aequor (Newbury Park, CA)
- … regulatory affairs processes and deliverables. Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …With the Head of Government Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategies, activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, ... the USA, alongside coordinating the global team.Responsibilities Lead and manage a global regulatory...preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in all regions. The Director of Dossier Planning will report to Head of Global Regulatory Operations and be an active participant on the Regulatory ... rare diseases and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible...and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs , and other relevant NNI departments to ensure alignment ... experiment with us? The Position The therapeutic area Operations Lead is responsible for supporting the therapeutic area One...marketing promotion. Act as a liaison between marketing, medical affairs , and market access. This role will have direct… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... with us? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an...for the US marketing initiatives in the context of global marketing. Coordinates closely campaign development, competitive defense, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy align with regulatory requirements and compliance standards. Collaborate with regulatory affairs and compliance teams to navigate regulatory ... landscapes Cross-Functional Collaboration: Collaborate closely with therapeutic area Lead , global commercial teams like CETA, customer experience strategy leads… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and compliance related areas. Oversight Provide strategic direction pertinent to CSPV Medical Affairs activities for internal QA team ( global / local), and not ... the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organizationSupport the global quality annual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... to experiment with us? The Position The Consumer Strategy Lead will be a pivotal driver in shaping an...for the US marketing initiatives in the context of global marketing. Coordinates closely campaign development, competitive defense, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs , and other relevant NNI departments to ensure alignment ... in? Are you ready to experiment with us? The Position The Brand Strategy Lead is pivotal in developing brand level objectives and strategic priorities. They will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP Experience Lead will play a critical role in ensuring the successful execution of brand/therapy ... cross-functional teams, including analytics, therapeutic area marketing leads, sales, medical affairs , market access and policy/advocacy (MAPA), and channel leads to… more
