- 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) ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory… 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 ... 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
- 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...Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical… 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, ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory ... biological entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country… more
- ICON Clinical Research (Farmingdale, NY)
- …helping shape an industry. As Regulatory Manager , you will work in Global Regulatory Affairs team, a successful and driven team that provides ... teams and have regulatory project management experience. The role: As a Regulatory Affairs Manager you will need to be experienced with In Vitro… 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...Days.** **This is a remote position.** Catalent is a global , high-growth, public company and a leading partner for… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory Strategy Group (GRS) collaborate with ... biomarker strategies across its growing clinical portfolio. The Sr. Manager , Regulatory Affairs IVD will...coordinated. + Represent RA IVD on clinical study teams, global regulatory study teams for assigned projects… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Jun 14, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 56073 **Who we ... with. **The opportunity** Teva Pharmaceuticals USA, Inc. is seeking multiple Managers, Regulatory Affairs (Parsippany, NJ) to evaluate change controls, provide … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Affairs will stay abreast of changes in the global /US/Canadian regulatory framework, analyze proposed legislation/guidance that could impact the ... hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development...Canada regulations is a plus. + Expert understanding of global regulations and regulatory agencies. + Demonstrated… more
- Vantage Specialty Chemicals (Fairfield, NJ)
- …it here. For more information visit: www.vantagegrp.com or LinkedIn/vantage **POSITION SUMMARY** Regulatory Affairs Senior Manager is responsible for leading ... Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs . The person will be responsible for personal care,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of ... regulatory affairs related to the development of...+ Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and… 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 ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …preparation of challenging communications + Manage the preparation for interaction with global regulatory authorities (eg, meetings, IR responses, inspections) + ... RA in a timely manner + Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC/CP prduct development… more
- Kedplasma (Fort Lee, NJ)
- **Position** : Regulatory Affairs Specialist **Location** : Fort Lee, NJ **DUTIES AND RESPONSIBILITIES:** 1. Ensures Regulatory compliance within KEDPLASMA ... Operating Procedures and other applicable Standards and Protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other … more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …Regeneron's Scientific Share of Voice securing positive patient outcomes. As a Sr Manager , Medical Affairs Project Management & Operations you will provide ... Business Planning & Execution ("SBP&E") is seeking a Senior Manager to provide strategic & operational project management excellence...project management support to the Global Medical Affairs Head and Medical Directors… 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...Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical… 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 ... 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
- TD Bank (New York, NY)
- …regulatory interactions across TD Bank, affiliates, and the US Holding Company. The Regulatory Relationship Manager I is the primary point of contact and ... in various agency meetings on behalf of RPM, and serves as primary Relationship Manager on assigned examinations or regulatory matters + Performs QC of all… more
