- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global ... will be responsible for the development and implementation of world-wide regulatory strategies for projects in their assigned therapeutic area portfolio.… more
- Merck (Trenton, NJ)
- **Job Description** The Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the ... point of contact, with significant experience, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling. This… more
- United Therapeutics (Trenton, NJ)
- … affairs or a related area of study or 7+ years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...a regulatory strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. + ... Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with advancements in… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. + ... Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay current with… more
- L'Oreal USA (Clark, NJ)
- …(https://careers.loreal.com/en\_US/jobs/SearchJobs) / 204454 Principal Scientist, Scientific & Regulatory International Affairs (SRIA) Americas, L'Oreal Research & ... & Innovation Full - Time 02-May-2025 Principal Scientist, Scientific & Regulatory International Affairs (SRIA) Americas, L'Oreal Research & Innovation - Clark,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects ... lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or...seek for this role. **U.S. Education & Experience** + PharmD/ PhD with 2+ years' relevant experience. + MA/MS/MBA with… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global...in a relevant scientific discipline required. Advanced degree (PharmD, PhD , MD, or DVM or MSc in Biology, Life… more
- Organon & Co. (Jersey City, NJ)
- …project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on ... Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role...development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. +… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more