- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Project Management and Strategic ... Regulatory Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management and Strategic Planning, you… 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 serve as an ad hoc member of Global Project Team (GPT)… more
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand… 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)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... supporting global needs as required. The RA Associate Director , Labeling will be overall responsible...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… 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 focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities… 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 ... products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible ... You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met for… more
- J&J Family of Companies (Titusville, NJ)
- …- 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Global Labeling Product Leader in Raritan, NJ; ... Associate Director , Global Labeling...experience. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least… more
- Merck (North Wales, PA)
- …with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's ... submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams...but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 ... responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the...individuals are current and up to date - Support regulatory inspection related activities as required - Support Head,… more
- Novo Nordisk (Princeton, NJ)
- …clinical development and regulatory requirements of a clinical program. The Associate Director will provide high level strategic input into development ... plans, study designs, and regulatory submissions. Relationships The Associate Director... global and local cross-functional study teams. The Associate Director should be seen as a… more
- S&P Global (New York, NY)
- …Level (for internal use):** 11 **The Team:** S&P's Network and Regulatory Compliance group offers best-in-class technology and incorporate industry best practices ... financial services industry with meeting their compliance obligations. Our risk and regulatory compliance management solutions create a single source of truth for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 ... + Leads CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... value from inception through to implementation. Demonstrates ability to handle global projects through established interactions with Japan and Europe as required.… more
- Amicus Therapeutics (Princeton, NJ)
- …with Technical Operations, Regulatory and other internal partners, the EQL Associate Director is actively engaged in ensuring outsourced manufacturing is ... Associate Director , External Quality Lead (Small...External Quality Lead (Small Molecule) Amicus Therapeutics is a global , patient-dedicated biotechnology company focused on discovering, developing, and… 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...other departments; Member of the Clinical Study Team and Global Clinical SubTeam + Maintains proficient understanding of therapeutic… more
- J&J Family of Companies (Raritan, NJ)
- …more at https://www.jnj.com/. Janssen Global Services, LLC is recruiting for an Associate Director , Global Cell Therapy Commercial Operations to be based ... in Raritan, New Jersey. The Associate Director , Global Cell Therapy...tactical plans, agency management, budget management, country support materials, legal/ regulatory review, message development and execution. + Ensures strategies,… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …your own career goals. **Job** **Title:** Scientific Associate Director **Location:** New Brunswick **Division:** Global Production & Supply/Pharmaceutical ... at all microbiological testing locations in the BMS network. The Scientific Associate Director will also ensure appropriate strategies for DP-related… more
- Merck (West Point, PA)
- …Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory -CMC, and Supply Chain. Associate Director ... **Job Description** **Position Description:** ** Associate Director ,** **Technology Transfer** **(TT)** **Systems...+ Demonstrated creative problem-solving skill. + Strong knowledge of global regulatory guidelines and cGMP principles. +… more