- Sumitomo Pharma (Trenton, NJ)
- …understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical ... Research & Development Activities + As a Regional Regulatory Lead, manage regional (United States and/or European) ...of the Global Regulatory Team (GRT), leads regulatory activities for assigned project (s) in line… more
- Sumitomo Pharma (Trenton, NJ)
- …of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical ... requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and...Health Authorities + Assist with development of the global regulatory functional plan through research , review and… more
- Bausch + Lomb (Trenton, NJ)
- …clinical , labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical , labeling,… more
- Organon & Co. (Jersey City, NJ)
- …the product lifecycle. + Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, ... timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- Sanofi Group (Morristown, NJ)
- …+ External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical ... possible. Ready to get started? **Main Responsibilities** **At the project level, the Clinical Lead, ECET will...Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial… more
- Sanofi Group (Morristown, NJ)
- …active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase ... regional labeling (eg, US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …or other programs. You will lead Regulatory Submission Teams or other Regulatory Project Teams and represent Global Therapeutic Area Regulatory on ... and help create possible, together. **Job Description** As an Associate Director, Global Regulatory Affairs, you will act as the Regional Regulatory Lead on… more
- Bausch + Lomb (Trenton, NJ)
- …mentor individuals on subject matter expertise + Provide guidance and direction regarding regulatory strategy to project teams + Participate in assigned due ... US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical...external regulatory stakeholders and shape the external regulatory environment. + Advanced Project Management /… more
- J&J Family of Companies (Titusville, NJ)
- …/medical issues + May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities ... appropriate post-doctoral training and certification + A minimum of 5 years clinical research or pharmaceutical industry experience is required, inclusive of… more
- Bristol Myers Squibb (Princeton, NJ)
- …Delivery Lead , is responsible for leading the delivery and management of the Research IT project portfolio , ensuring alignment with strategic priorities and ... Portfolio execution. Key Responsibilities + Lead the management and delivery of the Research IT project portfolio, ensuring alignment with the prioritized Book… more