The Associate Director of CMC Regulatory Affairs will serve as the global product leader for CMC regulatory strategy of one or more biological and/or small molecule products. This will include formulating and implementing global CMC regulatory strategies for the development of protein therapies, lead CMC regulatory activities for assigned projects in line with global requirements. Primary role includes:
- Serve as a liaison between the regulatory authorities and the company on CMC issues, with guidance from Team Lead and GRT
- Provide CMC RA leadership within GRA and on cross-functional CMC teams
- Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations
- Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls (10%)
- Provide CMC regulatory strategy for proposed changes, new development efforts, content message points, or other related activities, for commercial and/or development programs. (50%)
- Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%)
- Lead other development functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements. (15%)
- Evaluate manufacturing change controls, assess regulatory impact, and support their implementation. (10%)
Education & Experience Requirements
- B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
- At least 7 years of drug development/pharmaceutical industry experience (or equivalent) including significant strategic experience (5+ years) in CMC regulatory affairs (or equivalent) with a small molecule and/or biologics background.
- Demonstrated leadership in regulatory strategy and experience in regulatory interactions
Key Skills and Competencies.
- Excellent interpersonal, communication, analytical and managerial skills.
- Demonstrated experience with global development, registration and post-approval submissions
- Ability to work successfully with cross-functional teams and influence appropriate plans and actions.
- Strong attention to detail, establishing priorities, scheduling and meeting deadlines.
- Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.
- Ability to work independently, take initiative and complete tasks to deadlines.
Location/Region: Lexington, MA