- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development ... Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on approved… more
- Merck (Rahway, NJ)
- …Description** ** Associate Director , Portfolio & Program Management (PPM)** The Associate Director in Regulatory Planning and Publishing works closely ... execution, and management of activities that deliver high quality and timely regulatory and safety submissions for approval. The incumbent will be responsible for… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Global Regulatory Lead (GRL), reporting to the Executive Director , Senior Director or ... projects in their assigned therapeutic area portfolio. **Responsibilities** The Associate Director will be responsible to: + Develop regulatory strategy for… more
- United Therapeutics (Trenton, NJ)
- …like lungs, pancreases and hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory pathways, managing documentation and ... timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Are you looking to fundamentally… more
- Organon & Co. (Jersey City, NJ)
- …labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and most of ... labeling documents for company products, including Core, US and supporting country regulatory affiliates for consistency of labeling documents around the world. +… 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...products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will… more
- Organon & Co. (Jersey City, NJ)
- …Position** The Regulated Systems Business Oversight (RSBO) Strategy and Execution Associate Director with a focus on the Regulatory pillar is responsible for ... vision, strategy and roadmap. The RSBO Strategy and Execution, Associate Director reports into the RSBO Strategy...Director reports into the RSBO Strategy and Execution, Director , Regulatory Pillar within the RSBO team.… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory Chemistry, ... in accordance with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the ... of study data of a clinical development program. The Associate Director leads in a matrix environment...Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate… more