Director of Regulatory Affairs

VirtualVocations
Olympia Heights, Florida, United States
Full-time

A company is looking for a Director / Sr. Director, Regulatory Affairs, Immunology.Key ResponsibilitiesDevelop and implement global regulatory strategies for immunology productsLead the preparation of high-quality global submissions (IND, CTAs, BLAs, MAAs)Communicate with global Health Authorities and guide cross-functional teams on risk mitigation strategiesRequired Qualifications and EducationA minimum of 10 years of Regulatory Affairs experience in the biopharma industrySignificant experience in the therapeutic area of immunology / autoimmunity is preferredBS or higher degree in the life sciences;

advanced degree is a plusExperience as a global regulatory lead (GRL) for product developmentExtensive knowledge of regulatory requirements for drug development in a global environment

10 days ago
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