- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs , Regulatory Strategy to be a part of our ... Global Regulatory Affairs organization.In this role, you will...connecting with each other to innovate.About GenmabGenmab is an international biotechnology company with a core purpose guiding its… more
- Genmab (Plainsboro, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be ... of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs , the key responsibilities… more
- Merck & Co. (Rahway, NJ)
- …(Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will spearhead ... productsSupport device design control activities and documentation reviewsProvide evaluations of regulatory state of affairs of any devices and combination… more
- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading… more
- Genmab (Plainsboro, NJ)
- …US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross functional ... authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior Director, US Medical … more
- Merck & Co. (North Wales, PA)
- …legal and compliance colleagues across the Offices of General Counsel- including with US Regulatory Legal and International Legal & Compliance teams - to provide ... Job DescriptionJob ScopeThe Director, Corporate Affairs and Patient Innovation & Engagement Compliance has global compliance responsibility for all areas of… more
- Tris Pharma (Monmouth Junction, NJ)
- …in positions of increasing technical and strategic responsibilityExcellent working knowledge of regulatory and industry standards related to Medical Affairs role ... addressing unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products… more
- Insmed Incorporated (San Diego, CA)
- …team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality, and ... expertise to internal (Marketing, Sales, Manufacturing, Market Access, Patient Services, Regulatory Affairs , R&D, and Legal) and external (healthcare… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in… more
- Genmab (Plainsboro, NJ)
- …this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and ... and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM...connecting with each other to innovate.About GenmabGenmab is an international biotechnology company with a core purpose guiding its… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing ... regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Merck & Co. (Rahway, NJ)
- …stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency ... of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals.Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …required4 or More Years Minimum of 3 years of experience in regulatory affairs requiredProject Management knowledge and certification preferredProven ability to ... and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient resource management, and clear… more
- Merck & Co. (Millsboro, DE)
- …BTS-PD, BTS-Analytical, Operations, Engineering, Quality Control/Assurance, Supply Chain or Planning, Regulatory Affairs , Safety, and Research. Your main field ... working knowledge of current United States Department of Agriculture regulatory guidelines.Develops project charters and project plans and align with… more
- Merck & Co. (Rahway, NJ)
- …of the company's pipeline, including during late-stage development, distribution and regulatory milestones, in a manner that reflects the company's purpose and ... and manage all communications across the portfolio and pipeline, including regulatory approvals, governing bodies, publications of scientific data and other business… more
- Abbott (Plymouth, MN)
- …restore their health and get on with their lives. We are currently hiring an ** International Regulatory Affairs Specialist I** to work on-site at our ... market entry. **What You'll Work On** + Assist in the preparation of International regulatory applications (including annual reports) to achieve departmental and… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …accommodation to individuals with disabilities. **Brief Job Overview** The Policy Analyst, International Government and Regulatory Affairs (IGRA) is an ... This is an individual contributor role that will report to the VP, International Government & Regulatory Affairs . The role is also as an integral member of… more
- Amazon (Arlington, VA)
- …will deliver results across the world. You will report to the Head, Licensing & International Regulatory Affairs for Project Kuiper and work in close ... international telecommunications organizations. The Senior Lead, Licensing and Regulatory Affairs will shape regulations affecting non-geostationary satellite… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and technical files for registration of Olympus products in the EU. Interface with International Regulatory Affairs Team to support preparation of dossiers ... is likely not legitimate._ **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market...for registration for other international markets such as Japan, the Far East, Australia… more
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