I contribute to clinical research with expertise and empathy. And I do it
Regulatory Affairs Associate
Primary Location: India, Remote Job ID R0000043232 Category Regulatory Affairs Date Posted 06/30/2026Overview
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
An Associate must have a knowledge of the organization’s basic consulting models and methodologies as well as basic knowledge of what services PC provides. An Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. An Associate, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. The guidance of more senior staff may be needed to accomplish more complex tasks. An Associate may act in a client facing role with clear guidance and support from line management.
Key Responsibilities
• Support global regulatory lifecycle management activities across EU, US, and international markets
• Contribute to regulatory strategy development for global and regional submissions
• Prepare, coordinate, and deliver regulatory submission packages (Modules 1–5)
• Manage post-approval changes, variation submissions, and follow-up activities
• Handle Health Authority queries and ensure timely responses
• Provide submission management support including planning, coordination, and timeline tracking
• Maintain accurate records in Regulatory Information Management (RIM) systems
• Support safety-related regulatory activities such as aggregate reports and urgent safety updates
• Assist with audit, compliance, and inspection readiness activities
Desired Skills & Experience
• Strong knowledge of EU & US regulatory procedures and post-approval requirements
• Experience in global submission management and lifecycle maintenance
• Understanding of regulatory documentation and compliance standards
• Strong coordination and stakeholder management skills.
• 2 to 4 years of relevant experience
Educational Qualification
• B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
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