- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …we work every day is important to us.DOWNLOAD OUR CODE OF CONDUCT The Senior Manager , Regulatory Affairs will handle publishing and coordinating tasks for ... eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool.Support, maintain and update authoring templates.Assist… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) ... provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products...from MAPA leadership to our extended partners General: People manager for the MAPA Execution Team Lead short and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, ... need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, ... HR, and Legal).ResponsibilitiesTraining CommunicationsPlan, create, develop/build, draft and deliver various, innovative training vehicles to inform and educate employees on compliance issues through the utilization of existing and novel technological… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs - Regulatory Project Management ... (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Regulatory Affairs Project Manager ** **Position Summary** Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager **.** The ... Regulatory Affairs Project Manager is responsible for ensuring that the company aligns...aspects and climate that would affect proposed activities. The Regulatory Affairs Project Manager combines… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs CMC ... entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory … more
- dsm-firmenich (Princeton, NJ)
- Regulatory Affairs Manager /Personal Care Princeton, NJ, US Hybrid Are you passionate about the cosmetic and OTC sunscreen regulations in North America with a ... customer centric mindset? Join us in our journey! As a Regulatory Affairs Manager North America (NA), you will be part of a cross-functional team located in… more
- Novo Nordisk (Princeton, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The candidate will be leading the regulatory strategies for biologic products and combination products for the product portfolio assigned. **In this role, a typical ... + Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements… more
- dsm-firmenich (Princeton, NJ)
- Regulatory Technical Manager / Senior Manager Plainsboro, New Jersey, USHybrid / Remote / On-Site In this role our ideal candidate will serve as the lead ... regulatory support for DSM Firmenich / Campus ingredients and...customer service on projects, programs and/or processes to ensure regulatory compliance. Monitor and interpret food legislation, ensuring products… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications + ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, ... need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence,… more
- Ascendis Pharma (Princeton, NJ)
- …Medical - Endocrine Medical Affairs will report to the US General Manager with primary responsibility to lead the US Medical Directors and ensure the compliant ... Ascendis Pharma. . Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs... Regulatory to ensure that all US Medical Affairs activities and services are fully compliant with Ascendis… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …negotiations with Health Authorities. + Ensures labeling content conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages ... + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products… more
- WM (Trenton, NJ)
- …Stability. Growth Opportunities. People-First Culture (https://www.wm.com/us/en/inside-wm/who-we-are) . **About the Regulatory and Compliance Manager Role** The ... compliance, accuracy and efficacy of the information. The role Interfaces with the regulatory community and informing the WM public affairs professionals in… more
