- 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
- Sanofi (Cambridge, MA)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... expertise to contribute to the definition of the global regulatory strategy, to enable and drive...management of products. * May serve as a regional/local regulatory lead and point of contact with… 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
- Parexel (Concord, NH)
- …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
- Ralliant (Raleigh, NC)
- …a key legal advisor and strategic partner to the **_Assistant General Counsel, Global Regulatory and Government Affairs_** providing expert legal counsel and ... leadership across Ralliant's global regulatory and government affairs portfolio. The...on business operations and advising internal stakeholders accordingly. + Lead or support global initiatives and programs… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … lead the implementation of, process/system improvements related to regulatory submissions (Veeva Vaults RIM, Registrations, Publishing and AdPromoMats). May ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...in a fast-paced, team environment consisting of local and global team members. Analytical thinker with excellent problem-solving skills… 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
- 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
- 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
- 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
- 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
- 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
- ExxonMobil (Spring, TX)
- **About us** At ExxonMobil, our vision is to lead in energy innovations that advance modern living and a net-zero future. As one of the world's largest publicly ... will play in our team** Join ExxonMobil as a Regulatory Affairs Advisor supporting the Permian Business Unit. Become...leadership by collaborating on cross-functional teams to solve issues. Lead or advise Issue Management Team with a process… more
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