Under general supervision, CMC Regulatory Affairs Senior Associate is responsible for developing, coordinating and implementing CMC regulatory strategies for assigned projects. Specifically, the Senior Associate is responsible for providing strategic guidance to product teams by defining and optimizing regulatory strategies pertaining to the development, registration, commercialization and lifecycle management therapies in the United States and international markets. The role will serve as the liaison to, and oversees the regulatory affairs relationship with, US and International Health Authorities for CMC issues pertaining to assigned projects. Creates high quality, compliant CMC regulatory documents (e.g, Core Dossiers, CTAs, MAAs, NDS, Variations and other relevant regulatory CMC filings) within defined timelines.
Specific job functions include:
- Generate and maintain regulatory submissions
- Prepare responses to Health Authority questions and other correspondence
- Review labeling and marketing materials for compliance with Health Authority submissions and applicable regulations
- Conduct review of product and manufacturing changes for compliance with applicable regulations
- Utilize project tools to effectively track and communicate project development
- Implement and execute on regulatory plans and interface with project team members
- Manage multiple projects, client's initiatives and day to day tasks
- Keep abreast of regulatory requirements
- Minimum of 10+ years of experience in global drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities.
- Minimum of 5+ years in a Regulatory Affairs CMC role.
- Global regulatory CMC and/or Device experience required.
Telecommuting is allowed.
Internal Number: VGN-RA-001
About VictoGen Technical Solutions
We maintain end-to-end quality incorporating auditing, data integrity assessments, compliance, and global regulatory strategy and operations. We provide expert support to organizations of all sizes, life science investors and selected academic institutes. Our staff has the expertise, aptitude, and resourcefulness to determine where compliance improvements are needed.