- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Givaudan (East Hanover, NJ)
- …and Premarket Notification (PMN) Expert to join our dynamic team! As a Regulatory Affairs Technical Senior Manager , you will be an integral part of the ... Regulatory Affairs Product Safety (RAPS) team reporting...documentation and databases. Prepare reports and communicate findings to senior management and stakeholders. Be the primary contact for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management o Support the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, Customer Call Center, Enterprise Insights, Supply Chain, Procurement, Public Affairs , Public Policy, Regulatory , Legal, IT, Trade, Patient Safety ... Responsible for the compilation and processing of pharmacy redemptions for Senior Management approval Oversees vendor performance via regular status meetings,… more
- Merck & Co. (Rahway, NJ)
- …with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior -level and first-line ... teams both as a direct manager and a second line manager (ie, managers of managers)Demonstrated collaboration with senior cross-functional leadership in… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will ... trends governing the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs , Advertising and Promotion is… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …**Job Description** We are seeking a Lead Associate for our North America Medical Affairs team. This is a critical role within our Pharmacovigilance and Medical ... Affairs team. The incumbent will be directly responsible for...Serve as medial lead for meetings or responses to regulatory agencies * Work closely with Head, Pharmacovigilance and… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the ... Senior Manager of Regulatory Operations is responsible for... Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing, distribution,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager Statistical Programming for Medical Affairs provides timely support to the Medical Affairs project team on all programming matters ... through to regulatory approval, product launch, and annual reports. The Senior Manager Statistical Programming for Medical Affairs may serve as the… more
