Senior Regulatory Affairs Associate Jobs at Parexel for global submissions and lifecycle management across US, EU, Japan and other regions
Job Requisition ID: R0000037234
Job Type: Full-Time
Work Mode: Remote
Job Locations:
- India – Bengaluru (Remote)
- India – Hyderabad (Remote)
Industry: Clinical Research & Regulatory Affairs
Experience Level: Senior / Experienced
Application Mode: Online Application
Company: Parexel
About the Company
Parexel is a leading global clinical research organization (CRO) providing comprehensive solutions across clinical trials, regulatory affairs, consulting, and market access. Driven by a shared mission to improve global health, Parexel partners with biopharmaceutical companies to accelerate the development and approval of life-changing therapies. Senior Regulatory Affairs Associate Jobs at Parexel
At Parexel, every role contributes directly to improving patient lives. The organization is known for its strong scientific expertise, ethical values, collaborative culture, and commitment to quality and innovation across the product development lifecycle.
Job Details
- Job Title: Senior Regulatory Affairs Associate
- Employment Type: Full-Time
- Work Arrangement: Remote
- Job Locations: Bengaluru (Remote), Hyderabad (Remote)
- Functional Area: Regulatory Affairs
- Reporting Type: Individual Contributor
Job Description
Parexel is seeking a highly skilled Senior Regulatory Affairs Associate to support global regulatory submissions and lifecycle management activities. This role involves working on complex regulatory dossiers across multiple international markets and product types, including biologics, vaccines, and small molecules. Senior Regulatory Affairs Associate Jobs at Parexel
The position offers the opportunity to work independently while collaborating with global cross-functional teams to ensure timely and compliant regulatory submissions aligned with regional and international guidelines. Senior Regulatory Affairs Associate Jobs at Parexel
Skills / Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline
- Strong experience in Regulatory Affairs with exposure to global markets
- Hands-on knowledge of regulatory submission processes and lifecycle management
- Ability to work independently with minimal supervision
- Excellent written and verbal communication skills
- Strong collaboration and stakeholder management capabilities
Senior Regulatory Affairs Associate Jobs at Parexel
Key Responsibilities
- Handle new registrations, renewals, and lifecycle management activities
- Support regulatory activities for:
- Biologicals
- Vaccines
- Recombinant protein molecules
- Monoclonal antibodies
- Plasma-derived products
- Small molecule products
- Prepare, author (where applicable), review, and deliver regulatory submissions
- Manage Marketing Authorization Applications (MAA) and post-approval variations
- Support submissions across key global markets, including:
- United States
- European Union
- Japan
- Canada
- Switzerland
- Australia
- Contribute from both global and regional regulatory perspectives
- Ensure compliance with regional regulatory frameworks and procedures
- Maintain up-to-date knowledge of regulatory trends, guidelines, and legislation
- Apply ICH guidelines with a strong focus on CMC regulatory requirements
Senior Regulatory Affairs Associate Jobs at Parexel
Regulatory Expertise Required
- Strong understanding of global regulatory frameworks and procedures
- In-depth knowledge of pharmaceutical legislation and regulatory guidance
- Experience with both small molecules and large molecules
- Familiarity with regional regulatory trends and submission pathways
- Solid understanding of CMC-related regulatory requirements in ICH countries
Senior Regulatory Affairs Associate Jobs at Parexel
Benefits / Perks
- Fully remote work opportunity within India
- Competitive salary package aligned with experience and role level
- Opportunity to work on global regulatory programs
- Exposure to complex and innovative therapies
- Career growth within a globally respected CRO
- Inclusive, collaborative, and values-driven work culture
Senior Regulatory Affairs Associate Jobs at Parexel
Why You Should Join
- Contribute directly to therapies that improve patient lives worldwide
- Work with a globally recognized leader in clinical research and regulatory affairs
- Gain exposure to diverse international regulatory environments
- Enjoy flexibility with remote working options
- Be part of a mission-driven organization that values empathy, quality, and innovation
Senior Regulatory Affairs Associate Jobs at Parexel
Frequently Asked Questions (FAQs)
Is this role fully remote?
Yes, this position is offered as a remote role within India.
Which regulatory regions will I work on?
The role primarily supports US, EU, Japan, Canada, Switzerland, and Australia.
Is experience with biologics mandatory?
Experience with biologics, vaccines, or large molecules is strongly preferred, along with small molecule exposure.
Is this an entry-level role?
No. This is a senior-level role requiring solid regulatory affairs experience.
How to Apply
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
