I contribute to clinical research with expertise and empathy. And I do it
Regulatory Affairs Associate
Primary Location: India, Remote Additional Locations: India, Bengaluru Job ID R0000043744 Category Regulatory / Consulting Date Posted 08/11/2026Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Key Responsibilities
- Perform Regulatory Impact Assessments (RIA) for Change Controls raised in TrackWise.
- Assess regulatory implications of manufacturing, quality, labeling, and product information changes.
- Manage and maintain regulatory change records within Veeva RIMS.
- Support implementation of regulatory strategies for post-approval changes.
- Review, update, and author Module 3 sections of CTD dossiers for medicinal products.
- Ensure CMC documentation remains current and compliant with regulatory expectations.
- Support dossier lifecycle maintenance activities across multiple markets.
- Conduct comprehensive Gap Analysis of Module 3 documentation.
- Identify compliance risks, data gaps, and documentation deficiencies.
- Develop and recommend remediation plans and regulatory strategies to address identified gaps.
- Manage post-approval regulatory activities throughout the product lifecycle.
- Support maintenance of marketing authorizations across EU markets.
- Collaborate with cross-functional teams to ensure timely execution of regulatory commitments.
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