I contribute to clinical research with expertise and empathy. And I do it
Regulatory Affairs Associate-Annual report / Renewals(Biologics)
Primary Location: India, Remote Job ID R0000038455 Category Regulatory Affairs Date Posted 05/15/2026
Overview
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
Regulatory Affairs Associate
2 to 4 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Support Annual reports/Renewal experience US/ EU/Brazil/LATAM/China.
• Liaise closely with cross-functional members with aligned product responsibilities.
• Knowledge of change evaluation according to country guidelines
• Experience in managing lifecycle activities in the EU markets would be preferrable
• Knowledge of CTD guidelines
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