Andrea Email & Phone Number
Senior Director, Regulatory Affairs @ Alkermes
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Andrea Location
- Boston, MA, US
Andrea Work
- Senior Director, Regulatory Affairs @ (April 2024 - Present)
- Senior Director Regulatory Affairs @ (May 2023 - February 2024)
- Sunovion Pharmaceuticals @
- Senior Director Regulatory Affairs @ (June 2023 - March 2024)
- Senior Director, Global Regulatory Affairs @ (June 2022 - June 2023)
- Director, Global Regulatory Affairs @ (June 2019 - June 2022)
- Associate Director, Regulatory Affairs @ (January 2013 - June 2019)
- Regulatory Affairs Consultant @ Shire HGT (June 2009 - December 2009)
- Regulatory Affairs Consultant @ (October 2006 - February 2009)
Andrea Skills
- Biotechnology
- Chemistry, Manufacturing, and Controls (CMC)
- Clinical Development
- Clinical Trials
- Electronic Common Technical Document (eCTD)
- External Communications
- IND
- Investigational New Drug Application (IND)
- OPDP
- Pharmaceutical Industry
- Pharmaceutics
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Intelligence
- Regulatory Labeling
- Regulatory Requirements
- Regulatory Strategy
- Regulatory Strategy Development
- Regulatory Submissions
- Standard Operating Procedure (SOP)
- U.S. Food and Drug Administration (FDA)
- US Advertising & Promotional Review
- Veeva Vault
Andrea Summary
- Andrea, based in Boston, MA, US, is currently a Senior Director, Regulatory Affairs at Alkermes. Andrea brings experience from previous roles at Sumitomo Pharma America, Inc. and Sunovion Pharmaceuticals. With a robust skill set that includes Biotechnology, Chemistry, Manufacturing, and Controls (CMC), Clinical Development, Clinical Trials, Electronic Common Technical Document (eCTD) and more. Andrea has 3 emails and 2 mobile phone numbers on RocketReach.
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