- Novo Nordisk Inc. (Plainsboro, NJ)
- … the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Policy activities focused on the USA, alongside coordinating the global team.Responsibilities Lead and manage a global regulatory intelligence and policy ... JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation of a global approach (incl. processes,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. ... global strategy .Responsible for ensuring aligned global regulatory strategy is endorsed...or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- American Honda Motor Co Inc (Marysville, OH)
- …we want you to join our team to Bring the Future!About this Position: As a Global Mobility Team Lead you play a pivotal role in managing associate movement ... their actions align with the expectations of our organization. Lead the delivery of services and support provided to...Payroll, Finance, Legal, and external partners. Stay informed about regulatory , tax, and compliance rules governing global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Catalent (Manassas, VA)
- … Affairs and regulatory compliance. Will prepare for and lead regulatory meetings, designing regulatory compliance strategy to ensure compliance with ... Regulatory Affairs Position Summary: Catalent is a global , high-growth, public company, and a leading partner for...Associate Director, Regulatory Affairs is to support regulatory strategy for product development and manufacturing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... In this key role, the candidate will have to lead a complex, global team in charge... functions and commercial regional entities are reflected into strategy and plans.- The GTL ensures global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure that shared point data is current and accurate- In collaboration with the Lead Global QA Strategy and Operations (RDPVMA QA), Collate and produce ... R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This...to individuals are current and up to date- Support regulatory inspection related activities as required such as organizing… 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)
- …The purpose of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best ... the outsourcing strategy for the regulated bioanalytical sciences and will lead regulatory interactions related to bioanalysis and evaluates/sets the … more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you.Senior Manager, US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the development and execution of ... several marketing, strategy , and lifecycle planning projects focused on disease state...).Represent the brand with internal and external stakeholders, including Global and Regional colleagues. Ensure appropriate strategic direction is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development and execution of the tactical plan in support of the global brand strategy . The individual will serve as the lead point of contact with the ... book for indication execution the delivery, communication, and execution thereof- Develop and lead launch strategy at global level including positioning,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the… more
- Merck & Co. (Rahway, NJ)
- …leader engagement execution, target product profile development, health authority interactions, global regulatory filing strategy , organized customer ... supporting the Disease Area Strategies for Melanoma.Reporting to the Global Disease Lead for Skin Cancers, The...input on such activities as:target product profile (TPP) development, global regulatory filing strategy , launch… more
- Merck & Co. (Rahway, NJ)
- …and breadth of knowledge and understanding of scientific, medical, and regulatory environments, practices, and requirements.Demonstrated ability to lead and ... Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be… more
- Russell Tobin & Associates (Dublin, OH)
- …their trusted partner Attend meetings with municipal officials, engineers, developers, and contractors Lead or assist in the development of strategy , the scope ... work assignments to internal project teams and subcontractors Interact with regulatory agencies knowing what information to provide, when, and with appropriate… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development. ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary: The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in ... FDA and other health authorities globally- Creates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in… more
- Russell Tobin & Associates (Dublin, OH)
- …the Transportation Project Manager for the Great Lakes, this candidate will lead roadway expansion and improvement projects within the transportation team across the ... on how our services can meet their needs Identify regulatory drivers for our services and build a plan...client relationships as the client contact for projects Develop strategy , scope of work, and budget for projects and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes ... a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute … more
