- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure registration strategies adhere to therapeutic area direction and corporate objectives. Serve as Global Regulatory Lead or US regulatory lead ... to impact development programs. Additionally, this position interacts with Regulatory Affairs (RA) team members, cross-functional team...or global representation on project teams; may lead regulatory teams for more complex projects.… 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
- 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...pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience… 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)
- …and develop solutions. Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training ... materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management...Six Sigma method to support team processes. As the Global Labeling Lead product lead … 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
- 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)
- …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 ... around rare diseases and immune disorders. Summary In collaboration with assigned lead , responsible to assist in the accurate and timely administration and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … global commercial and global medical functions. As part of MALT (Medical Affairs Leadership Team) they will be working together with the VP MA to set the ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...(TA) head is accountable for setting an integrated medical affairs strategy, scientific engagement plan and execution of that… more
- Merck & Co. (Rockville, MD)
- …work in partnership with the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define ... Job DescriptionThe Global Regulatory Policy & Intelligence (GRPI)...Division's colleagues, regulatory liaison staff, and local regulatory affairs staff for submission of product… 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
- Merck & Co. (Rahway, NJ)
- …Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, business development ... engagement execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and… more
- Merck & Co. (Rahway, NJ)
- …effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Health Economics ... commercialization, including product development team, target product profile development, global regulatory filing strategy, launch readiness reviews, organized… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Legal, Manufacturing, Technical Transfer, Supply Planning and Global Customer Marketing and Commercial Execution to ensure optimized and successful ... Job DescriptionCompanion Animal Global Marketing - Director, Parasiticide Portfolio MarketingThe Companion...this new position, the Director, Parasiticide portfolio Marketing will lead the brand and product portfolio management of Parasiticides,… 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
- 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
- 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
