- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing ... global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory input to … more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director, Global Regulatory , Growth Markets will be responsible for providing regulatory ... and budgets for program activities and report accordingly.Lead and participate in global regulatory initiatives and committees. Requirements Bachelor's degree in… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …support for Medical Affairs Review Committee (MARC) Contribute to the development of regulatory strategy through assigned Global Regulatory team Lead ... A REMOTE BASED OPPORTUNITY IN THE UNITED STATES The Director, Global Medical and Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals' … more
- Insmed Incorporated (NJ)
- …you'll have a critical role in hands-on execution and oversight of global regulatory submission activities across assigned programs and market. Under ... operational execution, while supporting cross-functional teams to ensure alignment with global regulatory requirements and internal standards.What You'll Do:… more
- Eisai, Inc (Baltimore, MD)
- …strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and ... budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the… more
- Eisai, Inc (Nutley, NJ)
- …is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage ... regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to… more
- Eisai, Inc (Nutley, NJ)
- …along with a proven track record in inspection-facing roles and global regulatory compliance.Essential Functions Clinical Outsourcing Designs and executes ... business goals.Oversees Outsourcing function's adherence to ICH/ GCP guidelines, local regulatory requirements and SOPs/ SWPs on a global basis.Participates… more
- Merck & Co. (Rahway, NJ)
- …identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO ... to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations.… more
- Formation Bio (New York, NY)
- … GXP/PV/CSV regulations and guidance. Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health ... experience with oversight of CSV is preferred. Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise… more
- Merck & Co. (Rahway, NJ)
- …multiple large molecule programs across a variety of platformsExpert knowledge in global regulatory requirements for large molecule commercialization and BLA ... are developed by working teams supporting the product.Compile with our company's Global and regulatory requirements and execute current Good manufacturing… more
Related Job Searches:
Associate Director Global Regulatory,
Director Global Regulatory Affairs,
Director Global Regulatory Lead,
Global Regulatory Affairs Device,
Global Regulatory Lead,
Global Regulatory Policy Manager,
Manager Global Regulatory Affairs,
Senior Director Global Regulatory,
Senior Manager Global Regulatory,
Sr.director Global Regulatory