- 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
- System One (Somerset, NJ)
- …pharmaceutical industry in Quality/ Regulatory Compliance, Requirement: * Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage ... oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Participate...inspections by US FDA and applicable foreign regulatory authorities. Participate in all aspects of inspections from… more
- Medtronic (Annapolis, MD)
- …years with an advanced degree) **NICE TO HAVE** + Demonstrable understanding of US FDA regulatory requirements and policy + Regulatory experience within the ... medical device industry or a regulatory agency, such as the FDA + Experience in advocacy related to healthcare policy and regulations. + Ability to analyze… 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
- 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
- AdventHealth (Orlando, FL)
- …new drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA ; and coordination of the regulatory activities for AHRI led ... applications. Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities. Assists with the… 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
- Actalent (Altamonte Springs, FL)
- …drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA . The role also includes coordination of regulatory activities for ... applications. + Provide data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities. + Assist with… more
- ZOLL Medical Corporation (Chelmsford, MA)
- … FDA , EU Notified Bodies, EU Competent Authorities and other international regulatory authorities + Coordinates/prepare and maintains FDA PMA and 510(k) ... applicable CE certifications + Coordinates and prepares responses to FDA /NB or other such regulatory agency letters....prepares responses to FDA /NB or other such regulatory agency letters. + Supports Reviews of product labeling… 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 ... contract with potential to convert to permanentJob SummaryResponsible for preparing regulatory submissions required to market new or modified devices in both… 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 (Sylmar, 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
- 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
- Abbott (Plymouth, MN)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... and approving requests for product release. + May interface directly with FDA and other regulatory agencies if so directed. + Reviews protocols and reports to… 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
- AbbVie (North Chicago, IL)
- …Advise internal customers who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs, Clinical Development, Legal, and ... Description Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or… more