Andrea Kean
CMC Regulatory Affairs Consultant
- Role
- Regulatory Cmc Consultant at Takeda
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Andrea Kean
Accomplished biotechnology professional with 25 years of experience, including 11 years in Regulatory Affairs. Brings strategic and hands-on expertise leading global submissions for biologics, small molecules, and devices. Proven leader skilled at guiding cross-functional teams through complex global approval pathways. Highly adaptable, organized, detail-oriented, and collaborative with a team-centric work style.
Experience
Regulatory Cmc Consultant
Nov 2024 — Present
Education
University of Massachusetts Amherst
BS, Biochemistry
1992 — 1996
Massachusetts College of Pharmacy and Health Sciences
MS, Regulatory Affairs & Health Policy
2003 — 2005
Skills
- Aseptic Processing
- Regulatory Submissions
- Regulatory Affairs
- Technology Transfer
- Capa
- Gmp
- Biotechnology
- American Society for Quality (Asq) Certified Quality Auditor June 2002
- Pharmaceutical Industry
- Quality System
- Biopharmaceuticals
- Program Management
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