- 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
- Parexel (Providence, RI)
- …development of appropriate responses. - Participate in Safety Management Team (SMT) and Global Regulatory Team (GRT) meetings to provide expert input on ... environments and love the idea of being a key player in a global regulatory role - apply today! \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal… 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
- Organon & Co. (Jersey City, NJ)
- …for?assigned?products through the product lifecycle.?? + Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust ... assessment of CMC changes, identification?of? global ? regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and… 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 (Montgomery, AL)
- 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
- BeOne Medicines (Emeryville, CA)
- …and drive integration to therapeutic development plans. + Act as the representative of European regulatory team at the global regulatory team (GRT) for the ... and remote working possible **Location: Remote** **Reports To:** Executive Director, Global Regulatory Strategy, Dx/CDx and Medical Devices. All qualified… more
- Terumo Neuro (Aliso Viejo, CA)
- …teams and partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives. + Identify regulatory ... requirements for the markets identified and work independently in developing global regulatory strategy for assigned projects and develop approaches to… more
- CSL Behring (King Of Prussia, PA)
- … global oversight, leadership and direction to develop and execute global regulatory ad/promo strategies to support product commercialization, lifecycle ... within the pharmaceutical, biotechnology, or healthcare industry. -In-depth knowledge of global regulatory requirements and guidances (eg, EMA, Health Canada).… 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
- BeOne Medicines (San Mateo, CA)
- …of Business Excellence plays a pivotal role for driving the successful execution of Global Regulatory Operations Strategy & Innovation programs and projects in a ... in a group environment. + Familiarity with pharmaceutical development and Regulatory global submissions is a plus. + Excellent presentation and facilitation… more
- CSL Behring (King Of Prussia, PA)
- The Head of Global Regulatory Affairs - Advertising and Promotion is responsible for leading and overseeing the regulatory strategy and compliance of ... oversight, leadership and direction to develop and execute US and global regulatory ad/promo strategies to support product commercialization, lifecycle… 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
- Valvoline Global (Lexington, KY)
- …operations. This includes oversight of executive protection, facility security, global travel risk management, regulatory compliance, crisis response, ... **Why Valvoline Global Operations?** At **Valvoline Global Operations**...and corporate security procedures. + Ensure VGO's adherence to regulatory requirements including DHS, TSA, export controls, and privacy/data… 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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