- 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
- 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
- Bayer (Whippany, NJ)
- …minds to make a real difference, there's only one choice.** **Director US Regulatory Affairs Liaison** The Director US Regulatory Affairs Liaison develops US ... product approvals with optimized labeling. Ensures Bayer PH US Regulatory Affairs (RA) product registration activities are in line...and global R&D objectives and in compliance with all regulatory and legal obligations. This position will have to… 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
- Merck (Rahway, NJ)
- **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in delivering new medical advancements to patients around the world. ... and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the leading edge of… 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