Colleen Conway
Director, Cmc Regulatory Affairs @Humacyte
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WORK HISTORY
Director, Cmc Regulatory Affairs @Humacyte
Preparation of regulatory documents for IND, BLA, IMPD submissions (Module 2, Module 3)- Strategic development of responses to FDA Requests for Information; including drafting and submission of responses- Management of health authority commitments, including Post-Marketing Commitments- Post-approval change management, including assessment of change controls for impact to regulatory filings, preparation and submission of post-approval changes for health authority notification / approval- Review of quality events for BPDR reporting- System Administrator / Business Owner of Veeva RIM System (Submissions / Submissions Archive)- Preparation and submission of required periodic reports to health authorities
EDUCATION
Grand Valley State University
BS, Biomedical Science, Chemistry Minor
Eastern Michigan University
MS, Quality Management
ABOUT COLLEEN CONWAY
Authentic, high-performing leader with over 20 years of professional experience in the…
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