- Novo Nordisk (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
- J&J Family of Companies (Titusville, NJ)
- Senior Director , Global Regulatory Leader, CAR-T Therapy - 2406186120W **Description** Johnson & Johnson is currently seeking a Senior Director , ... have a positive impact on their communities. The Senior Director , Global Regulatory Leader, CAR-T...strategy, regional strategies, CMC-RA strategy, and commercial strategy. + Lead the Global Regulatory Team… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory ... Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management...and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… more
- J&J Family of Companies (Titusville, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …activities focused on the USA, alongside coordinating the global team. **Responsibilities** ** Lead and manage a global regulatory intelligence and policy ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...of leading Regulatory Intelligence, this role will lead the development and implementation of a global… more
- Sanofi Group (Bridgewater, NJ)
- …The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, ... of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as...truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role + 7 or More… more
- Sanofi Group (Bridgewater, NJ)
- **Our Team:** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and ... portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC...is comprised of more than 1800 people. The Device Regulatory Lead for Specialty Care & Vaccine… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... of prescription drugs, biologics, and devices. **ESSENTIAL FUNCTIONS** + Provide regulatory leadership and guidance to Commercial teams during the development,… more
- Ascendis Pharma (Princeton, NJ)
- …US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . ... The Regulatory Affairs (RA) Associate Director , Labeling...for the United States and the Americas and supporting global needs as required. The RA Associate Director… more
- Bristol Myers Squibb (Princeton, NJ)
- …to:** + New Product Portfolio working closely with their TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and ... and maintenance of global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities include, but are not… more
- Sanofi Group (Bridgewater, NJ)
- …in regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively with ... impact on the environment advise internal stakeholders on evolving regulatory policy issues, and more! The Director ...and communications with trade associations and health authorities on regulatory policy matters. + Lead proactive advocacy… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... role, a typical day might include the following:** + Provide interpretation of regulatory authorities' feedback, policies and guidelines. + Lead the development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, ... HA meetings as appropriate + In collaboration with therapeutic Regulatory leads and CDx lead develop key...RA Policy and Intelligence:** Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead + Recommend strategies and labeling language for ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where...the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that… more
- J&J Family of Companies (Raritan, NJ)
- Director , Global Medical Affairs Strategy and Execution, Specialty Ophthalmology - 2406188956W **Description** Johnson and Johnson Family is recruiting a ** ... disease (IRD) therapeutic area within the J&J Innovative Medicine Specialty Ophthalmology Global Medical Affair team. This individual will lead the development,… more
- Amicus Therapeutics (Princeton, NJ)
- …Associate Director , External Quality Lead (Small Molecule) Amicus Therapeutics is a ... Associate Director , External Quality Lead (Small Molecule)...Regulatory and other internal partners, the EQL Associate Director is actively engaged in ensuring outsourced manufacturing is… more