Director of CMC Regulatory
Virtual Vocations Inc, New York, NY, United States
A company is looking for a Director, CMC Regulatory.
Key Responsibilities:
Develop CMC regulatory strategies for U.S. and international markets in collaboration with cross-functional teams Plan, prepare, author, and review CMC-related submissions for various regulatory applications Monitor global regulatory requirements and trends, ensuring compliance and communicating impacts to stakeholders
Required Qualifications:
Minimum bachelor's degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science; advanced degree preferred 12+ years of experience in Regulatory Affairs or related role, preferably in biologics development Proven experience leading Regulatory CMC activities for regulatory filings in pre- and post-approval settings Thorough knowledge of biologics development, cGMPs, and regulatory submissions Experience with Emergency Use Authorizations (EUAs) and/or BLAs is a plus
Develop CMC regulatory strategies for U.S. and international markets in collaboration with cross-functional teams Plan, prepare, author, and review CMC-related submissions for various regulatory applications Monitor global regulatory requirements and trends, ensuring compliance and communicating impacts to stakeholders
Required Qualifications:
Minimum bachelor's degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science; advanced degree preferred 12+ years of experience in Regulatory Affairs or related role, preferably in biologics development Proven experience leading Regulatory CMC activities for regulatory filings in pre- and post-approval settings Thorough knowledge of biologics development, cGMPs, and regulatory submissions Experience with Emergency Use Authorizations (EUAs) and/or BLAs is a plus