- Aequor (Swiftwater, MN)
- …is a hybrid position. Mission The Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance for marketed products by means ... M&S, MSAT and GRA. The Regulatory CMC Specialist will ensure Regulatory compliance ...CMC topics, as well as North American, European and International regulations/guidelines Ability to manage multiple priorities efficiently Experience… more
- Merck & Co. (Rahway, NJ)
- …and/or results disclosures on ClinicalTrials.gov or EudraCT.Experience in authoring International Council for Harmonisation clinical/ regulatory documents (ie, ... of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document… more
- Merck & Co. (Durham, NC)
- …IQ, OQ, PQ, Change Control. Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.- Is expected to possess a high degree of ... Job DescriptionSenior Specialist , Quality Systems and Compliance (P3)...support and oversight of all production processes to ensure compliance with regulatory requirements as well as… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This ... and reporting/trending Reviews manufacturing and support records to certify compliance with specifications and procedures Works closely with Manufacturing and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …drug or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance ... reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regularly collaborate with various parts of the enterprise, including Compliance , Regulatory , Omnichannel Engagement, Market Development, Therapeutic ... Market Shaping, Diabetes and Bio Pharm Marketing, Sales, Medical Affairs, Legal, Compliance and other cross-functional stakeholders to plan and manage individual HCP… more
- Express Employment Professionals (Pasadena, CA)
- …Pasadena, CA. This critical role will oversee all aspects of our international shipping operations, ensuring compliance with global trade regulations, optimizing ... changes in import/export regulations and incorporate best practices to maintain compliance . Qualifications Bachelor's degree in international business ,… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific ... time management are important in the success of this position. The Sr Regulatory Compliance Specialist position maintains documentation for clinical research… more
- Catalent Pharma Solutions (Somerset, NJ)
- **Position Summary:** Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Regulatory Affairs Group. ... The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in...Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health… more
- Amazon (Sunnyvale, CA)
- …as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. ... regulatory timelines. * Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during … more
