- Insmed Incorporated (NJ)
- …each 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 ... product development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical… more
- Bayer (Whippany, NJ)
- …consistency, compliance to local and global HA regulations and completeness of submission; Lead a global regulatory team (GRT) and coordinate worldwide ... minds to make a real difference, there's only one choice. Director Global Regulatory Strategy (Molecular Imaging, Pharmaceuticals) The position is responsible… more
- Eisai, Inc (Nutley, NJ)
- …management of staff.Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... difference. If this is your profile, we want to hear from you. The Director, Global Regulatory , Growth Markets will be responsible for providing regulatory … 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 (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
- Merck & Co. (Rahway, NJ)
- Job Description Director Global Marketing Immunology - IBD Patient Strategy It is an exciting time to join our company's Immunology Team and our growing Global ... a key growth driver for our company. The Director, Global IBD Patient Strategy is responsible for shaping the...IBD patients in support of the launch of our lead asset in immunology. This role will develop a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... around rare diseases and immune disorders. Summary The Associate Director, Global Oncology Medical Affairs, Medical Analytics will be responsible for managing… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... include:Function as Business System Owner (BSO) of the current Documentum-based global submission content management solutionCo- lead the implementation of the… more
- Parexel (Trenton, NJ)
- …the development of appropriate responses. Participate in Safety Management Team (SMT) and Global Regulatory Team (GRT) meetings to provide expert input on ... developed, tracked, and delivered. Key Responsibilities: Serve as the global labelling lead for multiple products, providing...the idea of being a key player in a global regulatory role - apply today! #LI-LB1… more
