Harshali Pawar

Regulatory Affairs Specialist at Berkshire Sterile Manufacturing

Harshali Pawar is an experienced Regulatory Affairs Specialist currently working at Berkshire Sterile Manufacturing, where responsibilities include ensuring compliance with GMP standards and regulatory requirements during client audits and inspections. Previously, Harshali served as a Specialist II in Global Regulatory Operations at Cerevel Therapeutics, focusing on Veeva Submissions and documentation related to CMC and Medical Writing. Prior roles include mentoring students as a Student Success Guide at Northeastern University, assisting in regulatory affairs at Sigilon Therapeutics, and holding a junior executive position in regulatory affairs at Althea Pharma. Harshali holds a Master's degree in Pharmacy Administration and Pharmacy Policy and Regulatory Affairs from Northeastern University.

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Berkshire Sterile Manufacturing

Berkshire Sterile Manufacturing (BSM) provides the safest sterile drug products for clinical use and small-scale requirements through the use of modern technology, 100% isolator-based filling lines, and skilled staff.


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Headquarters

Lee, United States

Employees

51-200

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