- 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 ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and...a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term plans,… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales & Marketing, and Legal. ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical ... adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate… more
- 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
- Philips (Hamilton, NJ)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and product changes… more
- Novo Nordisk (Princeton, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Regulatory Affairs CMC - Vaccine + Location: Swiftwater, PA or Bridgewater, NJ (hybrid working schedule) + % of travel expected: < ... Chemistry Manufacturing and Controls (CMC) Team as a Manager and you'll develop the Global Regulatory ...CMC strategies for development and marketed products within Global Regulatory Affairs . You'll have direct contact/liaison with… 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
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …national origin, protected veteran status, disability or any other legally protected status. Manager , Regulatory Affairs : Base Salary Range $90,000 - ... from Veeva PromoMats on job volume and overall PRC performance. + Perform other regulatory tasks as assigned. **Requirements:** + Bachelor's Degree + 1 to 2 years of… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Regulatory Affairs Project Manager ** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... our business continues to grow and expand. Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager **.** The Regulatory Affairs … 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
- Abbott (Princeton, NJ)
- …of our **Princeton, NJ** location in the Abbott Point of Care Division. As a ** Regulatory Affairs Manager ** , your role involves combining knowledge of ... results. Individual is recognized as a discipline expert and resource in regulatory affairs . **Required Qualifications** + Bachelor's degree in science (biology,… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies ... Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is...market launch and product lifecycle management. The Strategist (Sr Manager ) works in a highly highly matrixed, global product… more
- Sumitomo Pharma (Trenton, NJ)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Senior Manager , Medical Strategy (Oncology) will be a key member of the ... Medical Affairs team reporting to the Executive Director, Medical ...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- US Tech Solutions (Titusville, NJ)
- …including: + Partnership across Medical Affairs , RW V&E, JRD, Brand Marketing, Regulatory Affairs , Global Medical Affairs , New Business Development, J&J ... should have a Doctorate, PhD, or PharmD + Will be monitoring trials, regulatory affairs , etc with competition + Will be responsible for Action Plans after… more
- System One (Raritan, NJ)
- Title: Global Medical Affairs Project Manager Location: Must be local Raritan, NJ and required to go onsite 2 days a week onsite Type: Embedded Start Date: ASAP ... Leading Pharmaceutical Company located in NJ is hiring a Global Medical Affairs Project Manager 3+ years industry experience. If you want to be a part of this… more
- Abbott (Princeton, NJ)
- …scientific dissemination of information + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global ... of ad promo materials or other assets which require medical/legal/ regulatory review + Organization & moderation of periodic Medical...Leadership Team + Supporting the Director of Global Scientific Affairs , in conjunction with the Sr. Manager … more
