- Vanderbilt University Medical Center (Nashville, TN)
- …requirements. . The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible ... Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our...identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior Director of ... updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs/ FDA Communications in managing, coordinating, tracking and… more
- BeiGene (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- BeiGene (San Mateo, CA)
- …of department policies. **Responsibilities:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- Catalent Pharma Solutions (Somerset, NJ)
- …industry in Quality Assurance, Pharmaceutical Manufacturing, or Compliance + Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage ... **Position Summary:** Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Regulatory Affairs Group. The… more
- Novo Nordisk (Lexington, MA)
- …advanced degree is strongly preferred + Minimum of 10 years drug development/ FDA / regulatory related industry experience required + Demonstrated knowledge of ... + Experience preparing teams for and leading meetings with regulatory agencies, including the FDA + Experience...leading meetings with regulatory agencies, including the FDA + Experience with rare disease drug development, innovative… more
- Actalent (Brea, CA)
- … regulatory affairs. + Knowledge of nutraceutical regulations. + Familiarity with FDA regulatory documents and labelling requirements. + Ability to review ... Job Title: Regulatory Affairs ManagerJob Description Ensure that marketing and...certifications for both imports and exports. Work alongside a Regulatory Consultant as needed. Notify federal bodies of any… more
- Medtronic (Santa Rosa, CA)
- …requiring regulatory agency review. Prepare submissions and reports for FDA or provide support and documentation for global submissions. + Maintain proficiency ... an extended core team member. + Assist in negotiations with the FDA or other regulatory agencies for assigned projects. + Other tasks, as assigned. **Must Have:… more
- Interstate Blood Bank (Vista, CA)
- …GBS DDL. + Assist Regulatory Management with product deviation reporting to the FDA . + Updates and distributes annual facility FDA reports. + Receive and ... Word, Outlook, Excel. + Advanced understanding of Good Manufacturing Practices (GMPs), FDA & EU Regulatory requirements. + Excellent interpersonal and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …plans. + Experience in preparation of critical submission documentation, and communications with FDA and other regulatory agencies. + Ability to build effective ... real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global regulatory guidance to cross-functional… more
- Kelly Services (Seattle, WA)
- …providing regulatory support and guidance on CMC -related submissions to the FDA and other regulatory authorities worldwide. You will assist in the ... and manages submissions to filings and supports review by regulatory authorities. + Liaises with FDA and...review by regulatory authorities. + Liaises with FDA and other regulatory authorities in written… more
- BeiGene (Emeryville, CA)
- …+ Ensure regulatory submissions are maintained in compliance with regulatory requirements. + Address device inquiries from FDA /HAs, IRBs/sites, and ... and CRO's as required. **Knowledge & Skills:** * Working knowledge of FDA and ICH regulatory guidance and regulations. + Understanding of FDA structure and… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …Knowledge of US and European/International regulations and standards + Experience interacting with FDA and/or other regulatory agencies + Must work well in team ... This is a 6+ month contract position. Job SummaryResponsible for preparing regulatory submissions required to market new or modified devices in both domestic… more
- Abbott (Pleasanton, CA)
- …required for product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory ... communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA... regulatory standards including those set by the FDA or other worldwide regulatory agencies to… more
- Houston Methodist (Houston, TX)
- …identified by the Manager. Assists in the preparation of periodic reports for FDA + Develops appropriate regulatory reports and associated documentation in ... **QUALITY/SAFETY ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- Abbott (Plymouth, MN)
- … affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies,… more
- Abbott (Sylmar, CA)
- …with FDA submissions and applicable regulations. + Interfaces directly with FDA and other regulatory agencies. + Supports the product release process ... regulatory requirements + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies,… more
- AbbVie (North Chicago, IL)
- …execution of the regulatory strategy. 7. Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses ... internal cross-functional team who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs, Clinical Development, Legal, &… more
- Beth Israel Lahey Health (Boston, MA)
- …to the FDA . + Preparation and submission of annual reports to the FDA ; submission of regulatory documents to NIH/OBA, local bio safety committees on oncology ... work experience required. + Must demonstrate good understanding of FDA , cooperative group, NCI and OHRP regulatory ...of FDA , cooperative group, NCI and OHRP regulatory guidelines. + Must maintain confidential and sensitive information,… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …timeline, submission activities focused on US/EU/Canada, and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **12271BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy...Strong technical writing skills as evidenced by successful US FDA Class II / III medical device submissions, EU… more
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