- 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
- argenx (Boston, MA)
- …argenx.I For the expansion of our regulatory team, argenx is looking for a Global Regulatory Lead , based in either Belgium, Switzerland or the East Coast ... The Director GRL is a key member of the global regulatory team. This role serves as...environment You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it… 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
- Eisai, Inc (Bethesda, OH)
- …strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and ... management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will...primary liaison between R&D functions, acting as the submission lead for designated global applications (eg, INDs,… more
- Merck & Co. (Rahway, NJ)
- …- Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate ... user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for...Proven leadership in Change Management with an ability to lead and influence others outside of a direct reporting… more
- Formation Bio (New York, NY)
- …and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support ... treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the… more
- Insmed Incorporated (NJ)
- …understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of... strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation… more
- Eisai, Inc (Bethesda, OH)
- …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
- Caris Life Sciences (Phoenix, AZ)
- …external requirements (FDA 21 CFR, ISO 13485, CAP/CLIA, PMDA, CMDCAS, and other global regulatory frameworks). + Lead investigations for Quality Events, ... issued are identified, resolved, and prevented in alignment with regulatory and internal Quality Systems requirements. The Analyst partners cross-functionally… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director and Global Lead , Patient Advocacy & Strategic Alliances position resides in the Value & Implementation (V&I) organization, ... Global Clinical Trial Operations (GCTO) and Data Project Lead (DLP) teams to ensure and assist awareness and...experience in global patient advocacy and engagement activitiesUS/ global experience in regulatory affairs, medical and… more
