I contribute to clinical research with expertise and empathy. And I do it
Senior Regulatory Affairs Associate
Primary Location: India, Remote Job ID R0000036892 Category Regulatory Affairs Date Posted 01/14/2026Overview
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
- 4-7 yrs in-depth knowledge of Indian regulatory guidelines for clinical trials, including NDCT Rules.
- Hands-on experience with SUGAM portal for Initial Clinical Trial Application (CTA/iCTA) submissions and amendments.
- Ability to liaise effectively with global sponsors and cross-functional teams.
- Prepare necessary documentation, presentations, and briefing materials for SEC meetings
- Strong understanding of global regulatory expectations and harmonization with Indian requirements.
- Acquired hands-on expertise in managing and completing clinical trial registrations on the Clinical Trials Registry-India (CTRI) portal.
- Updated with current Guidelines and Gazette Notifications to give suggestions/comments to respective Regulatory authorities and Govt. regulatory bodies.
- Working knowledge of India regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissions
- Manage timelines for query responses and ensure on-time submission through SUGAM portal or other regulatory platforms.
- Clear oral and written communication skills
- Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders as well
- Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Strong communications skills and ability to guide and mentor team members.
- Ability to work in different time zones
- Ability to work independently
#LI-REMOTE
Employee Insights
Why Consultants work at Parexel
