- Merck & Co. (Rahway, NJ)
- … Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... projects and teams as assigned.Key Accountabilities:Directs activities of the General Medicine global regulatory therapeutic area and team leading to global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization… more
- Eisai, Inc (Nutley, NJ)
- …Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post approval ... role requires experience with NDA/BLA, MAA and supplementary applications. Essential Functions Provide global regulatory leadership in support of the global … more
- Pall (Miami, FL)
- …the Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international ... turn ideas into impact - innovating at the speed of life.As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on… more
- Merck & Co. (Upper Gwynedd, PA)
- …and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical… more
- Eisai, Inc. (Nutley, NJ)
- …Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post approval ... role requires experience with NDA/BLA, MAA and supplementary applications. Essential Functions *Provide global regulatory leadership in support of the global … more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible ... regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling,… more
- Formation Bio (New York, NY)
- …clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a ... Regulatory Compliance & Submissions Ensure all CMC activities comply with global regulatory expectations (eg, FDA, EMA, ICH); author and review regulatory … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (San Francisco, CA)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project portfolio and prioritize and drive projects from inception through regulatory approval to global implementation.Requirements BS required, Ph.D. preferred ... manufacturing network and drive change management process from inception through regulatory approval to global site implementation.Candidate must have extensive… more
- Merck & Co. (Rahway, NJ)
- …execution, reporting and interpretation of data. Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Merck & Co. (Boston, MA)
- …day-to-day coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an...biologics and authoring regulatory documents (INDs, CSRs, CTDs) Required Experience: (a Ph.D.… more
- Merck & Co. (North Wales, PA)
- …and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Global Biologics Operations (GBO) organization is responsible for manufacturing and supplying commercial biologic products that support over $30 ... before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the Head of Global ... Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs, as well as, the GBO Leadership Team… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …years' experience in global labeling. This includes thoroughly understanding global regulatory labeling requirements and strategic labeling planning. Must ... per week on average. Position Summary The Director of Regulatory Affairs (RA) Labeling will lead the development of...and on market. This will include management of internal global Company Core Data Sheet (CCDS) process, labeling SOP,… more
- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... (SDS), product labeling, and SOP's. This role is crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory … more
