Divyani Patel, Pharm D, R Ph
About Divyani Patel, Pharm D, R Ph
Divyani Patel, Pharm D, R Ph, is a Regulatory Affairs Manager at Alkermes with extensive experience in regulatory affairs and pharmacy internships.
Current Role at Alkermes
Divyani Patel, Pharm D, R Ph, currently holds the position of Regulatory Affairs Manager at Alkermes. In this role, Patel is involved in overseeing global Clinical Trial Application (CTA) submissions for multiple Phase 3 studies across 14 outside-the-US (OUS) countries. She also manages query responses with internal reviewers and serves as the FDA point of contact for a marketed product. Additionally, Patel participates in regulatory affairs initiatives aimed at improving the company's internal regulatory standards and systems.
Previous Positions at Alkermes
Before her current role, Divyani Patel worked at Alkermes in several capacities. From 2018 to 2020, she served as a Senior Regulatory Affairs Associate. She also held the position of Regulatory Affairs Strategy and Intelligence Intern in 2018 and again in 2017, each for one month. These roles provided her with a robust foundation in regulatory strategy and intelligence.
Educational Background
Divyani Patel earned her Doctor of Pharmacy (Pharm.D.) degree from Massachusetts College of Pharmacy and Health Sciences, where she studied from 2012 to 2018. The comprehensive six-year program equipped her with the knowledge and skills necessary for her roles in various pharmaceutical and healthcare settings.
Early Career and Internships
Throughout her career, Divyani Patel has gained diverse experience through a series of internships and roles. These include positions at Biogen, St. Elizabeth’s Medical Center, VA Boston Healthcare System, The Medicine Shoppe Pharmacy, College Hospital Cerritos, Brigham and Women's Hospital, and CVS Health. These internships ranged from clinical supply and ICU pharmacy to pharmacy clerical duties and sales. Each role contributed to her broad expertise in pharmacy and regulatory affairs.
Responsibilities in Regulatory Affairs
In her various regulatory roles, Divyani Patel has co-precepted PharmD candidates through 6-week regulatory affairs rotations and guided associates in preparing official documents with minimal complexity. These responsibilities underscore her commitment to regulatory excellence and her role in mentoring future pharmacy professionals.