CMC Regulatory Affairs Manager
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- Title: CMC Regulatory Affairs Manager
- Location: Richmond, VA (possible remote for the right candidate)
- Industry: Pharmaceutical
- Hours: Mon-Fri 8AM - 5PM
- Salary: Competitive 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 (may consider contract for the right candidate)
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.
- Minimum 5 or more years of pharmaceutical industry experience with a focus on regulatory submissions experience. Work experience must include U.S. submissions to FDA of chemistry, manufacturing and controls (CMC) information. EU experience is desired, but not required.
- Experience with Regulatory submission processes from document authoring and management, submission publishing, to regulatory information management and archive
- Experience with Drug Master File (DMF), ANDA and NDA submissions, implementing EDMS applications, eCTD submission requirements and ESG
- Experience with sterile injectables within cGMP environment
- Must be proficient in MS Sharepoint, MS Office 360 (MS Word, MS Excel, MS Powerpoint), Adobe Acrobat Pro.
- Demonstrated entrepreneurial abilities, organizational skills, strong verbal and written communication skills, attention to detail and can work with all levels of personnel
- Bachelor s Degree in relevant discipline, with scientific discipline. Masters Degree highly preferred, but not required
Search words; chemistry, controls, manufacturing, CMC, regulatory affairs, quality, eCTD, sterile, injectables, NDA, ANDA, submissions, drug master file, DMF, pharmaceutical