Allison Kotas
Manager, Regulatory Affairs at Alnylam Pharmaceuticals
- Role
- Manager, Regulatory Affairs at Alnylam Pharmaceuticals
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Allison Kotas
I am a Regulatory Affairs Postdoctoral Fellow at Alnylam Pharmaceuticals, passionate about shaping regulatory strategy for pharmaceutical products across all stages of development. With hands-on experience in U.S. and global regulatory submissions, I lead the preparation, review, and submission of key filings such as IND applications and Fast Track Designation Requests. I have successfully guided cross-functional teams through complex regulatory processes, collaborated with agencies like FDA, EMA, and Health Canada, and established best practices for regulatory submissions. My expertise extends to advertising and promotion, labeling, chemistry, manufacturing, and controls (CMC), and pharmacovigilance, ensuring full compliance with regulatory standards.My goal is to continue advancing in regulatory strategy, where I can contribute to the success of innovative therapies and products on a global scale.
Experience
Manager, Regulatory Affairs
Jan 2025 — Present · Cambridge, MA, US
Education
University at Buffalo
Pre-Pharmacy, Cumulative GPA 4.00/4.00
2017 — 2019
University at Buffalo Pharmacy and Pharmaceutical Sciences
Doctor of Pharmacy - PharmD, Cumulative GPA as of November 2022: 3.98/4.00
2019 — 2023
University at Buffalo Pharmacy and Pharmaceutical Sciences
Doctor of Pharmacy - PharmD, Pharmacy
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.