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Harshali Pawar Email & Phone Number
Regulatory Affairs Specialist
at
Berkshire Sterile Manufacturing
LinkedIn matched
✓ Verified August 2026
3 data sources
Profile completeness 86%
Current company
Role
Regulatory Affairs Specialist
Location
Waltham, Massachusetts, United States
Company size
Who is Harshali Pawar? Overview
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Quick answer
Harshali Pawar is listed as Regulatory Affairs Specialist at Berkshire Sterile Manufacturing, a with 170 employees, based in Waltham, Massachusetts, United States. AeroLeads shows a matched LinkedIn profile for Harshali Pawar.
Harshali Pawar previously worked as Global Regulatory Operations Business, Specialist II at Cerevel Therapeutics and Student Success Guide at Northeastern University. Harshali Pawar holds Master'S Degree, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs, 3.8 from Northeastern University.
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Berkshire Sterile Manufacturing
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Profile bio
About Harshali Pawar
I am a highly motivated and experienced Regulatory Affairs Specialist with a passion for building innovative solutions. I have a proven track record of success in delivering high-quality Regulatory Submissions such as IND, NDA and 510 (k) on time. I am also a team player and I am always willing to go the extra mile.In my previous role at Cerevel, I was responsible for maintaining the quality of submissions along with managing the teams with scheduling important meetings. I have also been working with Veeva RIM and Share point to bring ease to the teams functionality while maintaining the quality of submissions.I am eager to take on new challenges and I am confident that I can make a significant contribution to your team. I am a quick learner and I am always willing to learn new things. I am also a creative thinker and I am always looking for new ways to improve the way things are done.
Current workplace
Harshali Pawar's current company
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Berkshire Sterile Manufacturing
9 roles
Harshali Pawar work experience
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Regulatory Affairs Specialist
CurrentThe Regulatory Affairs Specialist is pivotal in supporting regulatory and client-related activities within the Quality Assurance department. This role ensures compliance with GMP (Good Manufacturing Practice) standards and regulatory requirements during client audits and inspections. Responsibilities include maintaining regulatory documentation, responding to client information requests, managing inspection readiness, supporting audit and inspection responses, contributing to Quality Agreements, investigating complaints, and assisting with regulatory submissions. The Specialist must ensure adherence to FDA regulations, 21 CFR 210 and 211, and other relevant standards, applying their knowledge of cGMPs to maintain quality operations and regulatory compliance.
Jan 2024 - Present
Global Regulatory Operations Business, Specialist Ii
Supporting Veeva Submissions, along with CMC and Medical Writing documentation.
Sep 2022 - Sep 2024
Student Success Guide
Mentored students guiding them towards their educational goals and helping them build a path for themselves.Student data management and consultation were a part of the job
Jan 2022 - May 2022
Regulatory Affairs Assistant
Sigilon Therapeutics, Inc.
Prepared Standard Operating Procedures for Clinical Development procedures. Prepared and Maintained Study Records. Panelist on studying and answering the clinical questions from the IRB. Studied and presented the regulatory requirements for the approval of the product in the EMA.Preparing the team for internal Audits.Maintained Good Manufacturing Practices and prepared required SOPs
Jul 2021 - Dec 2021
Jr. Executive Regulatory Affairs
Prepared and compiled dossiers following the CTD and the eCTD format. Created the package insert and designed the artwork for labels for the new products manufactured.Conducted sample packing and dispatching for filing the authorization of the product in countries.Managed CMC activities for assigned products across the regionAssessed, approved, and released communication material (IFU, leaflets, brochures)
Jan 2020 - Aug 2020
Regulatory Affairs Associate
Applied the CTD and eCTD guidelines for the preparation of Dossiers for various countries. Introduction to the use of Form 1572 and Form 1571. Applied for Maintenance of ANDA for small and large volume parenteral.Sampling of drugs to be exported for the maintenance of ANDA.Designed package inserts and labels for the new products manufactured.
Jan 2019 - Dec 2019
Pharmacy Assistant
Clinical Consultation for Phase 3 patients of a chemotherapy drug trial. Carried out Patient Handling and Data management for patients undergoing chemotherapy.Dispensed Medications for the patients associated with the organization. Data Management of Case Report Forms and lab results.
May 2018 - Dec 2018
Pharmacist
Inventory Control and Patient drug Dispensing Patient Consultation while frug DispensingCalculation of the patient in and patient out times
May 2017 - Dec 2017
4 education records
Harshali Pawar education
Master'S Degree, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs, 3.8
Master'S Degree, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs, Ongoing
Bachelor Of Pharmacy - Bpharm, Pharmacy, 3.2
Bachelor Of Pharmacy - Bpharm, Pharmacy
Swami Vivekananda Institute Of Science And Technology
FAQ
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What company does Harshali Pawar work for?
Harshali Pawar works for Berkshire Sterile Manufacturing.
What is Harshali Pawar's role at Berkshire Sterile Manufacturing?
Harshali Pawar is listed as Regulatory Affairs Specialist at Berkshire Sterile Manufacturing.
Where is Harshali Pawar based?
Harshali Pawar is based in Waltham, Massachusetts, United States while working with Berkshire Sterile Manufacturing.
What companies has Harshali Pawar worked for?
Harshali Pawar has worked for Berkshire Sterile Manufacturing, Cerevel Therapeutics, Northeastern University, Sigilon Therapeutics, Inc., and Althea Pharma Private Limited.
How can I contact Harshali Pawar?
You can use AeroLeads to view verified contact signals for Harshali Pawar at Berkshire Sterile Manufacturing, including work email, phone, and LinkedIn data when available.
What schools did Harshali Pawar attend?
Harshali Pawar holds Master'S Degree, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs, 3.8 from Northeastern University.
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