I contribute to clinical research with expertise and empathy. And I do it
Senior Regulatory Affairs Associate
Primary Location: India, Remote Job ID R0000040066 Category Regulatory Affairs Date Posted 03/24/2026Overview
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
US & Canada Annual Report
- Compile list of Annual Reportable or Submitted/Approved CMC Changes.
- Strategy/Alignment Meetings (either actual meeting or e-mail exchanges).
- Prepare/Populate CMC Submission Content Plan (“SCP”) Preparation & Submission.
- Activities Module 1 authoring Liaise with appropriate functions to collect all required information to submit.
- Populate the SCP, including e-CTD attributes.
- Liaise with Regulatory Operations to ensure the publishing order and dispatch of CMC Dossiers.
- Follow-up with the Country Regulatory Manager (Affiliate) regarding receipt, submission, and acknowledgement by the Health Authority.
- Store all CMC Dossier and Administrative Documents in the appropriate repository system and close Regulatory Events in RIM.
- Simple Report includes up to 20 reportable changes and Complex Report includes up to 40 reportable changes.
Ideal Candidate Profile
- 5+ years of experience in Regulatory Affairs (Pharma).
- Understanding of US & Canada regulatory requirements for pharmaceuticals.
- Experience in module 1 authoring.
- Ability to handle multiple projects and meet submission deadlines.
- Comfortable working in a fast‑paced, compliance‑driven environment.
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