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CMC Regulatory Manager (Science & Biotech)
Durham, NC 27710
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Oct 09, 2020
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Job Description

The Manager Drug Regulatory Affairs is responsible for planning, managing and tracking regulatory documentation, and successful preparation and filing of submissions (DMF, ANDA, NDA) in the required electronic format. This role serves as the system owner for regulatory information tools and technologies, and develops processes to ensure submission are complete and comply with applicable regulatory requirements, in a fast-paced environment. This individual collaborates with cross-functional teams (RA, QA, IT, etc.) to bring excellence in regulatory planning and operational execution for development programs and post-approval management.

Working closely and partner with the Quality, Manufacturing and Development teams to track deliverables for preparation of regulatory submissions and other correspondence with FDA. Update management regarding status of deliverables and identify critical activities/risks for timeline.
Contributing to the creation and implementation of development and post-approval regulatory strategies for assigned projects and programs.
Contributing to the planning, preparation and review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.
Managing vendors in support of electronic publishing and other aspects of regulatory operations
Managing establishment registrations and drug listing requirements in compliance with FDA requirements, manage payment of establishment registration fees, and other fees (e.g.,GDUFA) associated with regulatory filings
Providing operational support as required for internal audits, FDA audits and FDA CGMP/GLP inspections
Assisting with imports, ensuring necessary documentation is provided for FDA clearance at Port of Entry
Assisting in tracking regulatory commitments and change control activities to ensure manufacturing changes are reported to authorities in accordance with regulatory requirements
Managing preparation of Annual Reports to FDA in compliance with obligations of the application holder
Providing leadership in regulatory information management, and as system owner for EDMS
Maintaining up-to-date knowledge of global standards and procedures for regulatory submissions, including FDA ESG, eCTD, IDMP, and ensure standards and procedures are compliant with these requirements.


Bachelor’s degree in relevant discipline, with scientific discipline preferred.

5 or more years of pharmaceutical industry experience with at least 3 years regulatory submissions experience. Work experience must include U.S. submissions to FDA of chemistry, manufacturing and controls (CMC) information.
An understanding of Regulatory submission processes from document authoring and management, submission publishing, to regulatory information management and archive

Experience with Drug Master File (DMF) and ANDA submissions

Experience in implementing EDMS applications

Experience wtih eCTD submission requirements and ESG