- 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
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, ... language against regulatory requirements. + Maintains awareness of global regulatory legislation and assesses impact to active marketed, established marketed… 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
- Insmed Incorporated (NJ)
- …and QC of regulatory documents prior to submission.Ensure adherence to global regulatory authority technical requirements (FDA, EMA, Health Canada, MHRA, ... be responsible for the publishing, management, and submission of regulatory documents in accordance with global health...submission of regulatory documents in accordance with global health authority requirements. The role has a strong… more
- Eisai, Inc (Bethesda, OH)
- …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
- Parexel (Columbia, SC)
- …EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering ... 5 years of biotech/pharma industry experience, including 2+ years in labeling/ regulatory operations with global responsibility. - Experience leading teams… 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
- 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...audits, etc. - Support regulatory requests for global markets. - Update and maintain regulatory … more
- Olympus Corporation of the Americas (Westborough, MA)
- …technologies and connected software systems. As needed provide input to define global regulatory strategy requirements. + Participate in teams for sustaining ... products to provide input on global regulatory requirements. + Support regulatory submissions, filings, and responses to regulatory or auditor inquiries… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Strong ability to align digital, business, and R&D leadership on global regulatory expectations, balancing compliance with innovation. + Strong problem-solving ... Description** This role is responsible for coordinating and managing regulatory activities across the Digital Unit (DU). The Digital...the Digital Unit (DU). The Digital Unit is a global , high-growth area focused on how digital technologies can… more
- Parexel (Bismarck, ND)
- …the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key ... Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for… more
- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is… more
- Parexel (Juneau, AK)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include… 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, ... Regulatory CMC. + Proactively fosters and promotes effective relationships across Global Regulatory Strategy. Updates and maintains applicable regulatory … more
- The Clorox Company (Durham, NC)
- …and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation Act (MOCRA)], global regulatory frameworks (including European Union, Canada and Asia ... care and over-the-counter (OTC) drug products. This role independently leads regulatory activities, ensuring compliance with global regulations while enabling… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …CFR, Part 820, Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements. The Global Vice President QARA Compliance is ... and provide recommendations. + Coordinates and leads audit activities with all global regulatory agencies (eg FDA, Notified Bodies, PMDA, NMPA etc.) + Creates… more
- Zscaler (Bellevue, WA)
- …frameworks while effectively making decisions amid ambiguity to navigate complex international/ global regulatory environments + Bachelor's degree required + ... and want to make a positive difference on a global scale, we invite you to bring your talents...Zscaler and help shape the future of cybersecurity. The Global People Compliance team is a strategic center of… more
- Oatey (Shakopee, MN)
- …Sigma, and continuous improvement. + Strong knowledge of quality systems and global regulatory compliance requirements. + Demonstrated business and financial ... a place where you matter?** **Position Summary:** The Senior Director, Cherne Global Operations will provide strategic leadership and oversight for Cherne (part of… more
- Signature Aviation (Orlando, FL)
- …CEBS, Certified Benefits Professional, SPHR) is preferred. + In-depth knowledge of global benefits programs, regulatory requirements and best practices. + ... The Director, Global Benefits will oversee the strategic planning and...and other employee benefits. + Ensure compliance with all regulatory requirements in each country. + Ensure all reporting… more
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