Regulatory Affairs Associate- Labelling
India, Remote Job ID R0000032359 Category Consulting Date Posted 03/25/2025Overview
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 expertise with medicinal products for changes with impact on Product Information - Safety / Labelling changes, including CCDS creation or updates
Experience:
1. 3-5 yrs of Regulatory Affairs experience in EU/UK/CH/AU/NZ:
- Safety Labelling changes with impact on Product Information and management of AW updates from an RA perspective
- CCDS creation or updates prior experience preferable
- Change control assessments
- Experience working on Centralized products is a plus
2. Veeva RIMS Knowledge.
3. Knowledge in using TVT Tool is a plus.
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