- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi ... with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate operational meetings with CROs, License Partners, ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development and ... 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 ... and Compliance. External relationships include affordability program vendors. Essential Functions Partners with vendors and oversees development of program business rules and operations Collaborates with cross functional partners to facilitate program setup… 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...NNI, a self-starter who is self-led and keeps their manager up to date on progress and ensures no… more
- Merck & Co. (Rahway, NJ)
- …work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior-level ... scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and...and maintaining high performing teams both as a direct manager and a second line manager (ie,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... templates, reviews agreements, and manages outside counsel as necessary. Global Government Affairs Acts as legal advisor for Government Affairs groups within… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will be an ... the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs , Advertising and Promotion is responsible for providing… more
- Stryker (Mahwah, NJ)
- We are currently seeking a **Senior Manager , Regulatory Affairs ** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). ... Mahwah, NJ or Weston, FL with some workplace flexibility. As the **Senior Manager , Regulatory Affairs ** , you will lead and coordinate global regulatory… more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . The primary responsibility of a Senior Manager in Commercial Regulatory Affairs is to provide ... applicable FDA regulations and guidance's. **Responsibilities include:** + Provide regulatory advice and risk assessment on concepts and final… 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
- Reckitt (Parsippany, NJ)
- …compliance support for Reckitt's local regulatory team. This position reports to the Regulatory Affairs & Safety Manager , Essential Home. You will be at ... Regulatory Affairs & Safety Associate, HH... Regulatory Affairs & Safety Associate, HH City: Parsippany **We...grow in our great organisation. **About the role** The Regulatory Affairs & Safety Associate, Regulatory… more
- Exelon (Mays Landing, NJ)
- …potential outcomes as requested. ** Regulatory Compliance** 1. Under the direction of the Regulatory Affairs Manager , act as a conduit for regulatory ... a rewarding career. Are you in? **Primary Purpose** **PRIMARY PURPOSE OF POSITION** ** Regulatory Policy** 1. Act to provide data and analytical support for specific… more
- Bausch Health (Bridgewater, NJ)
- …and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory development and ... industry and regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle + Knowledge of… more
- Reckitt (Parsippany, NJ)
- Sr. Manager , State External Affairs , NA City: Parsippany **We are Reckitt** Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our ... combination of impact, innovation, and excellence. As the Senior Manager , State Government Affairs , NA, you'll be...with internal key stakeholders in such as R&D, supply, regulatory and legal. + Build intelligence and understanding of… 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
- Abbott (Princeton, NJ)
- …scientific dissemination of information** **Cross-functional** **collaboration/interaction** **with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, ... established by the APOC Leadership Team** **Supporting the Director of Global Scientific Affairs , in conjunction with the Sr. Manager and Project Manager… more
- RWJBarnabas Health (Somerset, NJ)
- Regulatory Planning Manager (Hybrid) - Somerset, NJReq #:0000170498 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas Health ... - $129,204.00 per year Location: Somerset, Somerset, NJ 07052 Job Title: Manager Location: Barnabas Health Corp Department: External Affairs and Policy… more
