- GRAIL (Trenton, NJ)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a ... 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs . Global experience strongly...be directed to Chat with Ripley. R1596806 : Senior Director , Global Regulatory Lead Neuroscience… more
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory ... for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy… more
- Sumitomo Pharma (Trenton, NJ)
- …Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy ... of your application should be directed to Chat with Ripley. R1595190 : Director , Early Precision Medicine Regulatory Affairs **Company:** Bristol-Myers… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The ... role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply...parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs -...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Taiho Oncology (Princeton, NJ)
- …and coordinate regulatory activities of external consultants in consultation with Global Executive Director or designee. + Prepare project and/or status ... Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for...be required to perform other duties, as assigned. Job Details Job Family R&D Job Function Regulatory Affairs… more
- Coty (Morris Plains, NJ)
- …the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR...regarding OTC labeling and claims. Including working with the global artwork team to maintain the Coty Artwork guidelines.… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. ... on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg, FDA, EMA, PMDA) and align with ... The Director , Global Product Quality, GMP Processes...+ Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs , and technical operations to ensure… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …governance practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA) and internal ... **Job Summary** The Associate Director , Quality Operations will lead initiatives that drive...within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to… more
- Ascendis Pharma (Princeton, NJ)
- …their skills. The Regulatory Project Manager will be an integral part of Global Regulatory Affairs , providing project management leadership to key ... across the Ascendis pipeline. As a part of the Global Regulatory Affairs team, you...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- Bristol Myers Squibb (Madison, NJ)
- …Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs , and other Cell Therapy Development ... QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions. + Supports the overall product quality… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …for new products. Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …for assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned ... activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …quality issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA, EMA, ICH). + Prepare documentation ... The Associate Director of Global Supplier Quality will...outcomes. + **Cross-Functional Collaboration** + Collaborate with Procurement, Manufacturing, Regulatory Affairs , and Technical Operations to ensure… more
- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality ... for the preparation and approval of essential documents for global regulatory filings. The CL will manage...emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/device… more
