I contribute to clinical research with expertise and empathy. And I do it
Regulatory Affairs Associate- Local Regulatory Affairs Operations
Primary Location: India, Remote Job ID R0000043271 Category Regulatory Affairs Date Posted 07/01/2026Overview
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
This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.
Key Responsibilities
• 2+ yrs experience in support regulatory submissions including MAAs (Marketing Authorization Application), variations (minor/major), responses to questions, renewals, withdrawals, and marketing authorization transfers.
Working knowledge on EU procedures including centralized procedures coordination and management.
• Preparation and coordination for Module 1 activities for CMC, Safety, Administrative, MA transfer’s, Article 31 & other post approval variations & MAA’s.
• Assist with DHCP (Direct Healthcare Professional Communication) related activities and commitments follow-up
• Manage submissions through local Health Authority portals as required
• Handle post-approval lifecycle management activities and regulatory communication-RIMS
(Regulatory Information Management Systems)-VEEVA Vault
• Support linguistic review processes including translation review and coordination
• Conduct readability testing and support artwork (AW) review, mock-ups, and approvals
• Support promotional material review including Abbreviated Product Information
(API) creation or updates and Regulatory Affairs review processes (including UK pre-vetting)
• Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities at the country level.
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