- Sanofi Group (Morristown, NJ)
- **Job Title:** Manager , Global Regulatory Affairs - CMC - Vaccines **Location** : Swiftwater, PA or Morristown, PA **About the Job** Are you ready to ... families. Your skills could be critical in helping our teams accelerate progress. The Manager , Global Regulatory Affairs - CMC has the responsibility of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs , Precision Medicine, you ... regulatory strategy in alignment with the drug global regulatory strategy and in compliance with...Parsippany, NJ or Foster City, CA. **Responsibilites:** + Represent Regulatory Affairs Precision Medicine or Dx … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent ...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of ... guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s). + Prepare, coordinate and/or review all CMC and GMP related… more
- Teva Pharmaceuticals (Parsippany, NJ)
- * Manager , Regulatory Affairs Date: May 1, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 61105 **Who we ... a difference with. **How you'll spend your day** The Manager , Regulatory Affairs will: +...committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without… more
- Unilever (Hoboken, NJ)
- …high internal standards as well as with the technical aspects of legislation. UI Regulatory Affairs team leads this mandate and supports the entire Unilever ... Europe, and SEAA. As Unilever's growth engine, we establish global white space businesses in key channels such as...advocacy and expertise, this role will work with Unilever Regulatory Affairs community as well as with… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Senior Manager , International Regulatory Affairs , you will be responsible for Central Asia, South Asia, and Japan (CASAJ) and ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...You:** + Minimum BA/BS required. + Minimum 8 years regulatory affairs experience; or a combination of… 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
- Abbott (Princeton, NJ)
- …of information + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global Marketing & Commercial teams ... of strategic initiatives. . Ensures team member adherence to regulatory and compliance guidelines in all aspects of scientific...+ Supporting the Director of Global Scientific Affairs , in conjunction with the Sr. Manager … 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ... purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical… more
- Grifols Shared Services North America, Inc (New Brunswick, NJ)
- …FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… 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 an Senior Manager , Global Labeling Product Leader. This position...develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and… more
- Cardinal Health (Trenton, NJ)
- …and a host of other adult, pediatric, and neonatal enteral feeding products. The Global Portfolio Manager is an upstream marketing leader for the global ... Health's Medical Products Strategy in the NICU. Support developing business needs by: + Global product manager for NTrainer platform + Serve as product … more
- Integra LifeSciences (Princeton, NJ)
- …and evaluations + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line ... patient outcomes and set new standards of care. The Senior Global Product Manager - Upstream for Integra's Surgical Reconstruction (SR) Franchise identifies and… more
- Catalent Pharma Solutions (Somerset, NJ)
- … systems and sites. **EDUCATION AND** **EXPERIENCE** : Requires a Bachelor's degree in Drug Regulatory Affairs and 3 years of experience in job offered or 3 ... **INTERNET POSTING** ** ** **Job Title:** Manager Computer System Validation and Data Integrity **City:**...CAPAs relating to computerized GxP systems; Assure quality and regulatory compliance of global teams and sites;… more
- Fujifilm (Trenton, NJ)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... and commercialization for the Fujifilm Healthcare Americas Corporation IT portfolio. The Global Product Manager (GPM) is responsible for developing product… more