- 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
- Lundbeck (Deerfield, IL)
- …in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the development of end- to- ... Director US Regulatory Global Strategic Labelling Requisition ID:...in an optimal and compliant manner. **ESSENTIAL FUNCTIONS:** + Lead development of labelling strategy for new products and/or… 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
- 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
- Terumo Neuro (Aliso Viejo, CA)
- …and contribute into developing, editing, or revising regulatory processes. + Lead training for global regulatory processes and system implementations. ... partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives. + Identify regulatory requirements… more
- ITG Brands (Greensboro, NC)
- …regulatory and compliance guidelines by partnering with local and global Regulatory teams and stakeholders. + Lead team of subject member experts ... within the US market, as well as MMC in Global markets. + Lead team of subject matter experts, including global ... Global product initiatives meet both … more
- Parexel (Providence, RI)
- …development of appropriate responses. - Participate in Safety Management Team (SMT) and Global Regulatory Team (GRT) meetings to provide expert input on ... 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
- 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
- Organon & Co. (Jersey City, NJ)
- …through the product lifecycle.? + Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of ... guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for...CMC changes, identification of global regulatory requirements and critical evaluation of… more
- CSL Behring (King Of Prussia, PA)
- …of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, ... CMC. + Proactively fosters and promotes effective relationships across Global Regulatory Strategy. Updates and maintains applicable...products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the… 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
- Valvoline Global (Lexington, KY)
- …operations. This includes oversight of executive protection, facility security, global travel risk management, regulatory compliance, crisis response, ... + Conduct threat vulnerability assessments specific to executive visibility and event exposure. ** Global Travel Risk Management** + Lead a global travel… more
- SMBC (Charlotte, NC)
- SMBC Group is a top-tier global financial group. Headquartered in Tokyo and with a 400-year history, SMBC Group offers a diverse range of financial services, ... a diverse client base to local markets and the organization's extensive global network. The Group's operating companies in the Americas include Sumitomo Mitsui… 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
- 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
- Teleflex (Wyomissing, PA)
- …- Basic experience working with cross-functional teams. Preferred: - Basic medical device global regulatory knowledge base (outside of the US, EU, and Canada): ... device listings, establishment registrations, inspections, audits, etc. - Support regulatory requests for global markets. - Update...to adapt easily, and willing to take initiative and lead regulatory projects. - Proficient with Microsoft… more
- Kellanova (Chicago, IL)
- Are you ready to lead the future of global infrastructure at Kellanova? We're seeking a seasoned facilities engineering leader to drive high-impact building and ... A Taste of What You'll Be Doing + Champion Global Safety Standards - Lead the development...end of 2025 (subject to customary closing conditions, including regulatory approvals). The companies remain separate until closing. You… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Duties** + Strategic Leadership and Portfolio Alignment: + Facilitate development of global regulatory strategies for medical devices and digital health ... markets, such as North America, EMEA, Japan, and China. + Experience defining global regulatory strategies for digital health solutions in collaboration with… more
- Merck & Co. (North Wales, PA)
- 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
- Organon & Co. (Jersey City, NJ)
- …of all regulatory milestones for?assigned?products through the product lifecycle.?? + Lead development and execution of global product and project ... strategy(ies) by ensuring robust assessment of CMC changes, identification?of? global ? regulatory requirements and critical evaluation of supporting documentation… more
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