I contribute to clinical research with expertise and empathy. And I do it
Senior Regulatory Affairs Associate
Primary Location: India, Remote Job ID R0000039988 Category Regulatory Affairs Date Posted 03/23/2026Overview
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
A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. A Senior Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. A Senior 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. A Senior Associate may act in a client facing role with support from line management. When serving as a Project Lead or Work Stream Lead, a Senior Associate assures the work of the entire team or work stream is delivered on time and that it meets client’s and PC’s quality expectations.
EU Single/Workshare/Supergrouped Variation for CP and MRP (N&R and Established products) and HAQ support
Coordination of kick-off meeting and any other meeting and follow-ups
Reg Vault: creation of RO & SO and Submission content plan
Drafting of Cover Letter, Application forms
Navigating PLM portal for EU Application form Generation
Stakeholder Management
Finalization of submission content plans
Publishing request and QC of publishing output
Managing HA correspondences in Reg Vault
Shift: 12 pm to 9 pm IST
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