I contribute to clinical research with expertise and empathy. And I do it
Senior Regulatory Affairs Associate (Labelling)
Primary Location: India, Bengaluru Job ID R0000035749 Category Regulatory Affairs Date Posted 11/06/2025Overview
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
- Required minimum 4-6 years of experience in development of labeling of drug products (CCDS, USPI, packaging), product package coordination, supply chain regulatory affairs, and quality.
- Good working knowledge of key labeling regulations/guidance, and managing label updates, compliance, and governance.
- Strong knowledge of regulations pertaining to labelling life cycle management in US, EU, Switzerland, Canada and Australia.
- The ability to research and create comparator labeling documents.
- Strong understanding and experience authoring CMC component of Annual Reports.
- The ability to collaborate with technical teams for artwork implementation.
- Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
- Knowledge of usage of Electronic Document Management Systems and / or electronic submission experience.
- Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
- Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
- Monitor, manage and control artwork changes.
- To manage and maintain the Artwork Trackers & Systems.
- To ensure artwork PDFs are maintained and latest versions are readily available.
- Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved
- Experience with consumer advertising and educational materials
- Working experience in Regulatory Information Management Systems (RIMS) like, Veeva, TVT, Docubridge, etc.
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