Priti Baker
Sr. Regulatory Affairs Strategist at Biogen
- Role
- Senior Manager Regulatory Affairs at Biogen
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Priti Baker
Regulatory Affairs strategist with over 20 years of professional experience across product development for small molecules, drugs, biologics, antisense oligonucleotides, devices, and combination products.
Experience
Senior Manager Regulatory Affairs
Jan 2017 — Present · Raleigh-Durham-Chapel Hill, NC, US
Develop and execute U.S. and Global Regulatory strategies for drugs, biologics, antisense oligonucleotides, devices, and combination products in various stages of development and throughout product lifecycle • Identify and assess global regulatory risks to ensure compliance; provide strategic regulatory advice on key development issues • Prepare major global regulatory submissions, such as INDs and IMPDs as well as ongoing amendments; Accountable for managing responses to U.S. and Global Health Authority queries
Education
East Carolina University
Bachelor of Science, Biochemistry
1999 — 2003
The Johns Hopkins University
Master of Science - MS, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
2017 — 2021
North Carolina State University
Mathematics and Science Education Program
1991 — 1999
University of Colorado Anschutz
Pharmaceutical Biotechnology, John Carpenter
2005 — 2005
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