- 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)
- …participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities,… 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 ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a...of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all… more
- Pall (Miami, FL)
- …an advantage.Good understanding of applicable regulatory requirements covering Food Contact, Product Compliance (Ce Marking, ATEX, ASME etc.), Product ... related field or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of… more
- Sanofi (Morristown, NJ)
- Job Title: Director , Global Regulatory Affairs - Global Labeling Strategy Location : Morristown, NJ or Cambridge, MA (Hybrid) About the Job Are you ready to ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling...an active role in shaping labeling strategy early in product development by providing regulatory input into… more
- Genmab A/S (Princeton, NJ)
- …fit? Then we would love to have you join us! Genmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our ... and be responsible for the development, implementation and maintenance of US/global regulatory strategies (in line with Target Product Profile). As the… more
- Omega Medical Imaging LLC (Sanford, FL)
- …products. Key Responsibilities: Lead and continuously improve Omega's QMS to ensure regulatory compliance and product excellence. Guide 510(k) submissions, ... Be part of a company where your leadership shapes regulatory strategy and quality culture, driving both compliance... regulatory strategy and quality culture, driving both compliance and innovation. We offer competitive salary, PTO package,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Eisai, Inc (Exton, PA)
- …close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also ... Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of… more
- Merck & Co. (Durham, NC)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… 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
- 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- AstraZeneca (Gaithersburg, MD)
- Senior Director , Drug Product and Packaging Tech Transfer Location: Gaithersburg Be a Catalyst for Change at AstraZeneca Are you ready to lead with purpose and ... drive innovation that makes a global impact? Join AstraZeneca as our Senior Director , Drug Product and Packaging Tech Transfer , and play a vital role in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a highly skilled and experienced Director of Companion Animal Vaccine to lead our efforts in developing and managing our companion ... and vaccine development, with a proven track record of successful product launches and market penetration. This role requires exceptional marketing acumen… more
- Repligen (Waltham, MA)
- …, Quality - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...quality assurance team which includes all day-to-day activities for product manufacture, test and release including deviation support, root… more
- Fidelity Investments (Boston, MA)
- Job Description: Compliance Director , Fixed Income Compliance The Role Fidelity Institutional Compliance is seeking an associate to provide compliance ... clients and many of Fidelity's other businesses. The FCM Compliance Director will be responsible for providing...of new or amended regulations. Collaborating with the FI Compliance Regulatory Management team in regulatory… more
- Merck & Co. (North Wales, PA)
- …assessment of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise ... role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the… more
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