- Merck & Co. (Rahway, NJ)
- …global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirementsActively participate ... Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance , Regulatory Inspections, Vaccine… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product ...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Merck & Co. (Rahway, NJ)
- …participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... Immunochemistry, People Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC, Statistical Design of… more
- Twist BioScience (South San Francisco, CA)
- …and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements and ... The Regulatory Operations Specialist is responsible for ensuring the...Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. Collaborate with cross-functional teams to… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- TikTok (San Jose, CA)
- …to responsibly consume, create, and enjoy content on TikTok.Responsibilities - Lead global product compliance for all new and emerging laws, ensuring our ... products meet legal standards worldwide. - Create the product vision and roadmap for efficient, scalable compliance...strategically with legal and policy teams to identify critical regulatory themes and assess their impact on our users.… more
- Merck & Co. (Rahway, NJ)
- …understanding of medical device assembly equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding ... robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to develop… more
- Merck & Co. (Rahway, NJ)
- …matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Stakeholder… more
- Merck & Co. (Rahway, NJ)
- …Dublin, Carlow, and Wilmington-to successfully execute multiple New Product Introductions (NPIs), Process Performance Qualifications (PPQs), Pre-Approval Inspections ... (PAIs), and best-in-class multi- product launch manufacturing.To achieve this, this highly experienced leader...Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs, as well as, the GBO Leadership Team… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical… more
- Eisai, Inc (Raleigh, NC)
- …Quality area: Review manufacturing batch records for completeness, accuracy, and compliance with procedures to support timely product lot disposition.Maintain ... The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This… more
- Merck & Co. (Durham, NC)
- …projects Provide deep SME knowledge for manufacturing investigations support ( Product and process deviations and complex material-related) Collaborate with ... process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments Author or… more
- Aequor (Thousand Oaks, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting ... and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend coverage will be ... that Shift(s) objectives are achieved while reliably supplying quality product at a competitive cost consistent with our Company,... at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for… more
- Merck & Co. (Rahway, NJ)
- …change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Engineering, Chemistry, Clinical Operations, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …and vaccine development, with a proven track record of successful product launches and market penetration. This role requires exceptional marketing acumen ... research and development of new vaccines, ensuring they meet regulatory requirements and industry standards.Collaborate with cross-functional teams, including R&D,… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety...management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for… more
- Aequor (Hicksville, OH)
- …etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and ... are operating the lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up… more
