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Parexel International
Parexel Senior Regulatory Affairs Associate Recruitment 2026: Apply Online
Senior Regulatory Affairs Associate – Local Regulatory Affairs Operations
Experience Required
4+ Years
Salary / Package
Competitive Corporate Package
Work Mode
Remote / Hybrid
Openings
Multiple
Job Overview
- As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate complex regulatory landscapes.
- Manage post-approval regulatory activities including variations, renewals, and compliance with country-specific requirements.
- Partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.
- Prepare and coordinate Module 1 activities for CMC, Safety, Administrative, MA transfers, and post-approval variations.
- Handle submissions through local Health Authority portals and utilize RIMS (VEEVA Vault).
- Support linguistic review processes, readability testing, artwork review, and promotional material review.
- Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities.
Key Job Details
| Company Name | Parexel International |
| Job Role | Senior Regulatory Affairs Associate – Local Regulatory Affairs Operations |
| Experience | 4+ Years |
| Salary Range | Competitive Corporate Package |
| Job Type | Full-time |
| Work Mode | Remote / Hybrid |
| Openings | Multiple |
| Job Location | India (Bengaluru / Remote) |
Key Responsibilities
- Support regulatory submissions including MAAs, variations, responses to questions, and renewals.
- Work with EU procedures including centralized procedures coordination and management.
- Prepare and coordinate Module 1 activities for CMC, Safety, and Administrative tasks.
- Manage submissions through local Health Authority portals.
- Handle post-approval lifecycle management and regulatory communication using VEEVA Vault.
- Support linguistic review, translation coordination, and readability testing.
- Assist with PSUR submissions and country-level regulatory intelligence activities.
Requirements & Qualifications
- 4+ years of experience in regulatory submissions and operations.
- Working knowledge of EU regulatory procedures and centralized processes.
- Familiarity with regulatory databases and systems like VEEVA Vault.
- Strong interpersonal skills: communicator, detail-oriented, problem-solver, and relationship-builder.
- Degree in Life Sciences, Pharmacy, or equivalent discipline.
Required Skills
- Regulatory Submissions
- EU Regulatory Procedures
- VEEVA Vault / RIMS
- Module 1 Preparation
- Lifecycle Management
- Communication & Problem Solving
About Parexel International
Parexel is a leading global clinical research organization (CRO) dedicated to accelerating the development of innovative new therapies to improve patient health. We provide comprehensive clinical development, regulatory consulting, and commercialization services across the globe.
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Frequently Asked Questions
Q: What is the role of a Senior Regulatory Affairs Associate?
A: The role involves managing post-approval regulatory activities, variations, renewals, and compliance with country-specific requirements.
Q: How many years of experience are required?
A: Candidates must have 4+ years of experience in supporting regulatory submissions such as MAAs and variations.
Q: Is remote work allowed for this position?
A: Yes, Parexel offers flexible remote work arrangements for this role.
Q: What tools or systems are used in this role?
A: The role utilizes Regulatory Information Management Systems (RIMS) such as VEEVA Vault.
Q: How can I apply for this position?
A: You can apply online directly through the official Parexel Careers Workday portal using the provided application link.
Disclaimer: This job post is prepared by collecting data from the official career page of Parexel International. We are not direct recruiters or representatives. Candidates should carefully review the requirements and policies on the company’s portal before initiating an application.