Minal Jain

Seniour Regulatory Affairs Associate Labelling

Role: Seniour Regulatory Affairs Associate at Parexel
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

About Minal Jain

A Regulatory Professional having 6.5 Years of Experience in Pharmaceutical Industry, Specialised in labelling submission for Regulatory Authorities across the EU and UK.Experience in implementing labelling updates aligned with CCDS and managing safety variation post approvals Submission, Including Type 1Ain,IA, IB, PRAC,PSUR, CMDh.Skilled in reviewing and assessing Change control,Related to safety and labelling and Mock-ups update to ensure regulatory compliances.Proficient in using Labelling tools E-Harmony, Karomi,TVT, OAMS, Omi text Verifications.Submission software-Educe,PharmaReddy, Docubridge.

Experience

Seniour Regulatory Affairs Associate
Parexel
Sep 2025 — Present · Bengaluru, IN

Education

Poona College of Pharmacy, Pune
Master's Degree
2017 — 2018

Contact information

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Work email
•••••@parexel.com
Personal email
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Current company

Parexel

Pharmaceutical Manufacturing · 22K employees · Raleigh, North Carolina, United States

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

parexel.com

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About Minal Jain

Experience

Seniour Regulatory Affairs Associate

Education

Poona College of Pharmacy, Pune

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