I contribute to clinical research with expertise and empathy. And I do it
Senior Regulatory Affairs Associate-Diagnostic Imaging and Interventional Radiology
Primary Location: India, Remote Job ID R0000038452 Category Regulatory Affairs Date Posted 04/15/2026
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
CMC authoring, pharmaceutical products- Diagnostic Imaging and Interventional Radiology
- Knowledge of contrast media, injection solutions in medical imaging (MRI/CT)
- Authoring of the CMC part of dossiers including coordination and review with stakeholders for Worldwide submissions such as EEA, US and other regions
- Experience in managing new registrations, life cycle maintenance, and renewals for medical imaging products
- Delivery of regulatory submissions from a global and regional perspective, regulatory change control assessments, preparing responses to health authority questions
- Good understanding of the regulatory framework, including regional trends, for various types of applications and procedures for imaging pharmaceuticals for worldwide filings, specifically linked to CMC aspects.
- Expertise with regulatory management system and document management systems.
- Effective communication and collaboration skills, and the ability to work independently.
5 to 8 Years of relevant experience
#LI-REMOTE
Employee Insights
Why Consultants work at Parexel
