- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Strong Project Management Intermediate proficiency… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager , Regulatory Affairs Date: May 30, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 61105 **Who we ... new people to make a difference with. **How you'll spend your day** The Manager , Regulatory Affairs will: + Prepare, review and approve regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs , Precision Medicine, you will help ... either Parsippany, NJ or Foster City, CA. **Responsibilites:** + Represent Regulatory Affairs Precision Medicine or Dx Regulatory in cross-functional teams… 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include… more
- City National Bank (New York, NY)
- *GRC REGULATORY AFFAIRS AND GOVERNANCE MANAGER * WHAT IS THE OPPORTUNITY? Position reports to the Head of Regulatory Affairs & Governance in the GRC ... affecting US business platforms. * Develops improvement approaches for the GRC Regulatory Affairs & Governance group within the GRC Office that are holistic,… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… 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)
- …values drive our collective progress and impact. Job Scope: 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
- Daiichi Sankyo Inc. (Basking Ridge, 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… more
- City National Bank (New York, NY)
- *BUSINESS AFFAIRS MANAGER * *WHAT IS THE OPPORTUNITY?* This position is a multi-faceted role that will work directly with the City National Rochdale (CNR) ... Director of Business Affairs to support various activities across the wealth management...compliance activities, legal engagement, internal or external audits, and regulatory responses . * Contribute to and be responsible… more
- WuXi AppTec (Plainsboro, NJ)
- **Overview** The Government Affairs (GA) Manager will be responsible for the daily management of the US government relations and related stakeholder engagement ... WuXi AppTec's operations in the United States, including legislative and regulatory developments. + Create and review briefing materials (Word, PowerPoint, etc.)… more
- Veterans Affairs, Veterans Health Administration (New York, NY)
- Summary The Pharmacy Program Manager is responsible for developing and managing technology-based solutions and informatics to promote safe, effective, and optimal ... vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications Applicants pending the completion of… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Cardinal Health (Trenton, NJ)
- …of internal and external regulatory policies. Leverage broad knowledge of regulatory affairs , quality management systems and business operations to develop ... + Bachelor's degree in scientific or compliance field, eg, Legal, Regulatory Affairs , Engineering discipline, or equivalent work experience, preferred… more
- Grifols Shared Services North America, Inc (New Brunswick, NJ)
- …8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or ... Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 527460 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Johnson Innovative Medicine R&D is recruiting for a Senior Manager , Global Labeling Product Leader. This position is a...develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and… more
