CMC Regulatory Affairs Manager
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● Title: CMC Regulatory Affairs Manager
● Location: Williamsburg, VA
● Industry: Pharmaceutical
● Hours: Mon-Fri 8AM - 5PM
● Salary: Generous compensation. If direct hire, one’s medical benefits (including family) is 100% covered, up to 30% target bonus (individual and company performance), stock options and 30 days PTO.
● Employment Type: Direct hire
Environment: Join a start-up pharmaceutical manufacturing company dedicated to providing high-quality, low-cost pharmaceuticals through state-of-the-art, U.S. based advanced manufacturing processes. The company will manufacture precursor chemical ingredients, active pharmaceutical ingredients (API), and finished pharmaceutical products, domestically for essential medicines critical to the ones’ healthcare. To help ensure the quality, safety, and affordability of pharmaceutical products of strategic importance to the United States this client utilizes advanced manufacturing platforms, including continuous manufacturing, to provide essential medicines to its customers, health systems, and government partners.
The CMC Regulatory Affairs Manager 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.)
● Working closely 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.
● 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
● Contributing to the planning, preparation and review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.
● 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
● 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.