- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the Regulatory Affairs ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in regulatory labeling operations and process optimization. Experience with project coordination or operational support in a corporate setting. Familiarity ... around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time… more
- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... product development for assigned programs. This role will provide regulatory input to global cross-functional project teams...care you bring to your work each day, with support for how you work, how you grow, and… more
- Insmed Incorporated (NJ)
- …processes and regulatory environmentsStrong technical knowledge of medical affairs applications and IT infrastructureProficiency in project management ... serves as a strategic liaison between Information Technology and Medical Affairs departments, driving technology initiatives that support medical excellence,… more
- Cipla (Fall River, MA)
- …committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, procurement etc. ... management. In collaboration with Cipla commercial, supply chain management and regulatory affairs , responsible for launch planning, launch risk mitigation… more
- Syner-G BioPharma Group (Boston, MA)
- …systems, and energy management.Collaborate with internal stakeholders including EHS, IT, and Regulatory Affairs to support compliance and operational ... and maintain SOPs, maintenance logs, and documentation for inspections and audits. Support regulatory inspections and ensure compliance with OSHA, EPA,… more
- Eisai, Inc (Bethesda, OH)
- …implement recommendations for resolution.Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)Technical Skills RequiredAdvance working ... also includes resource planning, budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate… more
- Merck & Co. (Rahway, NJ)
- …policies and procedures.Prepare the Final Study ReportMaintain contact with all stakeholders ( project leader, regulatory affairs , quality assurance etc.) and ... and report clinical laboratory and field studies that will support the regulatory approval of new companion...also be responsible for several effectiveness studies within a project , participating as the clinical representative in project… more
- Merck & Co. (North Wales, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Insmed Incorporated (NJ)
- …Are:You have a Bachelor's degree along with 5+ years of experience in Medical Affairs , Regulatory Affairs , or related functions within the pharmaceutical or ... ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials.… more
- Eisai, Inc (Nutley, NJ)
- …with Legal and other cross-functional colleagues to provide guidance and support on Artificial Intelligence (AI) initiatives and governance, and conducting ... and awareness initiatives. The Associate Senior Counsel will also be expected to support the HR team on employee benefits issues, including counseling on privacy… more
- Boehringer Ingelheim (Athens, GA)
- Description Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global ... their assigned projects. This role is responsible for linking regulatory affairs information to internal and external...model to drive Target Product Profile objectives. Provides consistent regulatory advice to project teams regarding the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …market access and commercial perspective. Additional Duties & Responsibilities US-Focused Project Team Support : Provide US regulatory strategic ... in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a...taking on leadership of the information as appropriate. Global Project Team Support : In collaboration with the… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …us. Functional/Organizational Summary This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy Automation ... Master's degree in life sciences field (preferred over Bachelor's) RAC certification ( Regulatory Affairs Certification) PMP certification ( Project Management… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director, Regulatory Affairs Date: Dec 2, 2025 Location West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 65114 ... people to make a difference with. The opportunity The Associate Director, Global Regulatory Affairs , will be responsible for providing regulatory guidance… more
- GRAIL (Boise, ID)
- …to optimally position GRAIL products with the FDA and/or global health authorities. Support the US Regulatory Affairs team in preparing submissions ... cross-functionally with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional… more
- Merck & Co. (Omaha, NE)
- …Finance, IS Audit, Policy Development, Policy Implementation, Policy Procedures, Problem Solving, Project Risk Assessments, Regulatory Affairs Management {+ ... to our Company's Global Supply Chain Director, the Specialist will support the development and implementation of global trade compliance policies, procedures,… more
- Dentsply Sirona (Milford, DE)
- …enhancing business relationships. Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, ... FDA 510(k) submissions and EU technical files submissions. Provides regulatory guidance and support to cross-functional teams...degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. … more
- Meta (New York, NY)
- …as needed Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions ... Summary: We're seeking a regulatory affairs specialist to join our...All significant issues will be reviewed with the manager Support regulatory compliance activities, including site registration,… more
- ThermoFisher Scientific (Austin, TX)
- …Information This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within an office setting, following a ... compliance in our innovative Animal Health product lines. The Regulatory Affairs Specialist III will be responsible...for defining and implementing regulatory strategy, providing regulatory guidance and support to product development… more
