Regulatory Strategy Lead, Vaccines & Biologics
Job in
Glen Burnie, Anne Arundel County, Maryland, 21060, USA
Listed on 2026-07-31
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-31
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Healthcare Compliance
Job Description & How to Apply Below
Jobtailor is seeking a regulatory affairs professional to develop CMC strategies for vaccines and manage FDA submissions for IND/BLA activities. You will coordinate with R&D, manufacturing, and QA to ensure FDA and global compliance with GMP standards, serving as a primary FDA contact and leading agency discussions.
The role emphasizes regulatory risk assessment, cross-functional communication, and mentoring junior staff in lifecycle management and post-approval changes in biologics.
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