This individual will support pre-approval compounds in the development phase through marketing registration and post approval follow up. Responsible for implementation of practical, workable plans to support all CMC regulatory filings. Oversees and participates in all CMC submission-related activities for CTAs, INDs, NDAs, MAAs. Works closely together with the CMC teams for small and large molecules. Represents the regulatory voice and CMC expertise on the team. Responsible for advising the teams on compliance with regulations and guidelines. Also ensures CMC regulatory strategy is in alignment with the global regulatory strategy, regional strategies, commercial strategy, and the Target Product Profile (TPP).
FibroGen’s research and development areas include first in class novel oral treatment of anemia and an injectable monoclonal antibody used in the treatment of fibrotic diseases.
• Responsible for CMC filings supporting the progress of Phase I through Phase IV development of drugs, biologics and devices.
• Maintains an in depth level of understanding of the company’s compounds, their characteristics, manufacturing aspects and specifications/analytical methods
• Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to include DMFs, INDs, CTXs, NDAs, BLAs, IDEs, PMAs, etc. and required amendments. Hands-on participation in submission preparation is expected.
• Reviews technical reports and summary documents (chemistry & manufacturing) for adherence to regulatory guidelines, strategies, and commitments.
• Contributes to writing expert summaries of CMC submissions.
• Maintains an advanced level of understanding and awareness of existing and forthcoming legislation and guidelines related to CMC. Advises project teams accordingly
• Participates in or leads CMC meetings with regulatory agencies
• Provides regulatory expertise and policy support for GMP
• Effectively tracks metrics, milestones, and deadlines to ensure timely submissions
1. At least Bachelor’s degree in a scientific discipline. Minimum of 6 years of experience in Regulatory Affairs.
2. Strategic thinker, planner, and implementer. Excellent organizational skills.
3. Real experience with pharmaceutical CMC filings for INDs, NDAs and BLAs filing experience in Asian countries is a plus.
4. Expert knowledge of FDA and foreign regulations and guidelines in the CMC area. Must be familiar with EOP2 meeting for CMC in small molecules.
5. Independent individual, able to plan and execute complex projects, proven record of delivering results within business-defined timeframes.
6. Experience leading and coaching staff. Maintains a positive team spirit.
7. Ability to formulate and deliver crisp communication.
8. Knowledge of GMPs
9. Proficiency in MS-word, excel, powerpoint, project mgr, adobe.