Colleen Conway
Experienced Quality / Regulatory Leader
- Role
- Director, Cmc Regulatory Affairs at Humacyte
- Location
- Grand Rapids, MI, US
- LinkedIn followers
- 500 followers
About Colleen Conway
Authentic, high-performing leader with over 20 years of professional experience in the…
Experience
Director, Cmc Regulatory Affairs
Apr 2023 — Present
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
1998 — 2002
Eastern Michigan University
MS, Quality Management
2005 — 2010
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