- Merck & Co. (North Wales, PA)
- …Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD ) to provide strategic regulatory input and approvals.Conduct initial content review ... Job DescriptionAt the heart of innovation, our Regulatory Affairs team plays a vital...to ensure successful registration and compliance.Primary Responsibilities Develop and lead global regulatory strategies to support multiple… more
- Merck & Co. (Millsboro, DE)
- …Material(s):N/ARequired Skills:Adaptability, Audits Compliance, Communication, Detail-Oriented, Drug Regulatory Affairs , Employee Training Programs, Global ... with applicable USDA regulations and is within the Global Regulatory Affairs Bio team. This position is... strategy with interdepartmental teams for pre and post license of US Biologicals.Additionally, may assist as an Alternate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...skills.Job-Specific Competencies & SkillsDemonstrated ability to understand, manage and lead in a multi-cultural atmosphere, with an employee base… more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations).Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck & Co. (Rahway, NJ)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, … more
- Merck & Co. (South San Francisco, CA)
- …as immunology, neurology, cardiometabolic and others as needed by the pipeline.Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... scientific direction of companion diagnostics (CDx). - Specifically, the Diagnostics Lead will develop and execute diagnostic strategies and interact with various… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs , including reviews/approvals of Change Control Reports ... several branded ADHD products in the US We also license our products in the US and ex-US markets....methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management,… more
- Merck & Co. (Rahway, NJ)
- …industry standards.Collaborate with cross-functional teams, including R&D, marketing, sales, and regulatory affairs , to ensure the successful launch and ... seeking a highly skilled and experienced Director of Companion Animal Vaccine to lead our efforts in developing and managing our companion animal vaccine portfolio.… more
- Caldera Medical (Westlake Village, CA)
- …the Quality of Life for Women! Message from the Hiring Manager: The Director of Regulatory Affairs will lead global regulatory strategy, manage ... MDR Technical Files, and global market registrations, ensuring successful licensing and compliance. * Serve as primary liaison with...diligence for mergers and acquisitions. * Build, mentor, and lead a high-performing regulatory affairs … more
- J&J Family of Companies (Horsham, PA)
- …PA; Spring House, PA; Titusville, NJ; or Raritan, NJ. The Director, CMC Regulatory Affairs Biologics New Modalities will lead a team of CMC regulatory ... and programs. + Lead planning, organization, and resource allocation within CMC Regulatory Affairs , focusing on new modalities, such as CGT. Partner with… more
- GE Vernova (Wilmington, NC)
- **Job Description Summary** The US Licensing Manager, Regulatory Affairs , will lead a licensing team and manage the completion of various ... teams on major projects. **Job Description** **Essential Responsibilities:** As the US Licensing Manager, Regulatory Affairs , you will: + Manage the… more
- Takeda Pharmaceuticals (Boston, MA)
- …departmental and cross-functional taskforces and initiatives. + Serves as lead regulatory reviewer in due diligence for licensing opportunities. + Partner ... order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing innovative global … more
- Ameren (Steedman, MO)
- …provided to regular full-time employees. Job Description **About The Position** The Regulatory Affairs / Licensing Engineer provides support to the ... and licensing issues. **Key responsibilities include** Regulatory Affairs : + Provide critical review of...accordance with the requirements of 10CFR50.59. + Serve as lead for Electronic Licensing Document Issues All… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced ... typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager… more
- Vistra (Shippingport, PA)
- …or decommissioning. + Lead , mentor, and develop a team of regulatory affairs professionals, fostering a culture of accountability, compliance, and continuous ... currently available and apply online. **Job Summary** The Director, Regulatory Affairs is a senior leadership role...This position plays a critical role in maintaining the license to operate, driving regulatory strategy, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …in departmental and cross-functional task-forces and initiatives. + Lead regulatory reviewer in due diligence for licensing opportunities. + Partner ... to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for developing innovative global… more
- Merck (De Soto, KS)
- …are submitted in compliance with applicable USDA regulations and is within the Global Regulatory Affairs Bio team. This position is based in the US however ... N/A **Required Skills:** Adaptability, Audits Compliance, Communication, Detail-Oriented, Drug Regulatory Affairs , Employee Training Programs, Global Communications,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, ... and associated documentation. + Provide expertise as the Global Regulatory Lead to Product Development Teams and... regulatory single point-of-contact for products within Global Regulatory Affairs and outside. + Communicate new… more
