Jason Shen
Director, Regulatory Affairs - CMC at Insmed
- Role
- Director, Regulatory Affairs - Cmc at Insmed Incorporated
- Location
- Summit, NJ, US
- LinkedIn followers
- 500 followers
About Jason Shen
18 years’ regulatory and technical experience in pharmaceutical industry.• Experienced Regulatory CMC project lead responsible for CMC regulatory strategy and CMC dossiers for global submissions including IND/CTA, NDA, and MAA, as well as regulatory life-cycle management of mature products for different dosage forms and drug-device combination products.• Proficient in leading a team to timely deliver responses to regulatory review questions. • Effective communication and coordination skills for interacting with internal and external stakeholders including regulatory agencies.• Extensive CMC technical knowledge and experience in drug development and manufacturing aspects including GMP compliance.• Excellent experience in leading and participating in different global and cross-function initiatives.
Experience
Director, Regulatory Affairs - Cmc
Jun 2021 — Present · Bridgewater, NJ, US
Plan, execute and manage regulatory submissions for oral dosage forms and drug-device combination products (inhalation) in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various teams. • Identify the gaps and challenges of CMC development and provide regulatory strategies to ensure the approvability of the drug products worldwide and the qualify compliance for IND/IMPD CMC amendments and post-approval changes. • Develop the plans for the preparation of CMC meetings with the regulatory agencies, and draft and review regulatory documents for CMC meetings with the agencies.• Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations and regulatory advice to CMC development plan and activities to ensure CMC compliance within regulatory filings. • Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues during product development at various development stages and product lifecycle.
Education
University of New Hampshire
Ph.D, Analytical Chemistry
2001 — 2006
University of Science and Technology of China
BS, Polymer Physics
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