Parexel has announced a new opportunity for the position of Regulatory Affairs Associate under its Consulting team. The role is primarily remote in India, with Bengaluru listed as an additional location.
The company is looking for experienced regulatory professionals with 3+ years of experience in post-approval regulatory activities for medicinal products registered through European regulatory procedures, including CP, MRP, DCP, and National Procedures.
This is a suitable opportunity for professionals with expertise in Regulatory Affairs, CMC documentation, Module 3 dossiers, lifecycle management, regulatory impact assessments, and European post-approval submissions.
Parexel Regulatory Affairs Recruitment 2026 – Overview
| Particulars | Details |
|---|---|
| Company Name | Parexel |
| Job Role | Regulatory Affairs Associate |
| Department | Parexel Consulting |
| Primary Location | India – Remote |
| Additional Location | Bengaluru, Karnataka |
| Work Mode | Remote |
| Employment Type | Full-Time |
| Experience | 3+ Years |
| Functional Area | Regulatory Affairs |
| Application Mode | Online |
Job Summary
The Regulatory Affairs Associate will support biopharmaceutical and medical device clients with regulatory strategies and post-approval activities. The role focuses on maintaining marketing authorizations, managing regulatory changes, preparing CMC documentation, updating CTD dossiers, and supporting regulatory submissions across European markets.
The selected candidate will work with cross-functional teams and regulatory professionals to ensure products remain compliant with applicable regulatory requirements throughout their lifecycle.
Key Responsibilities
The selected candidate will be responsible for:
- Perform Regulatory Impact Assessments (RIA) for change controls raised through TrackWise.
- Assess regulatory implications of manufacturing, quality, labeling, and product information changes.
- Manage and maintain regulatory change records in Veeva RIMS.
- Support the implementation of regulatory strategies for post-approval changes.
- Review, update, and author Module 3 sections of CTD dossiers for medicinal products.
- Ensure CMC documentation remains accurate, current, and compliant with regulatory requirements.
- Support regulatory dossier lifecycle management across multiple markets.
- Conduct detailed gap analysis of Module 3 documentation.
- Identify compliance risks, missing information, and documentation deficiencies.
- Develop remediation plans to address identified regulatory and documentation gaps.
- Recommend appropriate regulatory strategies based on identified gaps and product requirements.
- Manage post-approval regulatory activities throughout the product lifecycle.
- Support maintenance of marketing authorizations across European Union markets.
- Coordinate with cross-functional teams to ensure regulatory commitments are completed within required timelines.
Work From Home Job Contract Specialist at Parexel
Experience Required
Candidates should have:
- 3 or more years of relevant Regulatory Affairs experience.
- Strong experience in post-approval regulatory activities.
- Experience with medicinal products registered through European procedures, including:
- Centralized Procedure (CP)
- Mutual Recognition Procedure (MRP)
- Decentralized Procedure (DCP)
- National Procedures
- Experience in regulatory lifecycle management.
- Knowledge of CMC documentation and CTD Module 3.
- Experience supporting regulatory submissions and health authority requirements.
Required Skills
The ideal candidate should have knowledge or experience in:
- Regulatory Affairs
- Post-Approval Regulatory Activities
- European Regulatory Procedures
- CTD Dossiers
- Module 3
- CMC Documentation
- Regulatory Impact Assessment
- Change Control
- TrackWise
- Veeva RIMS
- Regulatory Lifecycle Management
- Marketing Authorization Maintenance
- Gap Analysis
- Regulatory Strategy
- Compliance Assessment
- Health Authority Interactions
- Regulatory Submissions
- Cross-Functional Collaboration
Educational Qualification
The provided job description does not specify a particular degree requirement. Candidates with a relevant scientific, pharmaceutical, medical, or life sciences educational background and appropriate Regulatory Affairs experience may be suitable for the role.
Key Responsibilities in Post-Approval Regulatory Affairs
This position primarily focuses on maintaining products after regulatory approval. The professional will assess proposed manufacturing and quality changes, determine their regulatory impact, update relevant CTD documentation, and support submissions required to maintain marketing authorizations.
Strong knowledge of CMC and Module 3 documentation is therefore particularly important for candidates applying for this position.
Salary Details
Parexel has not disclosed the official salary package for this Regulatory Affairs Associate position.
The actual compensation will depend on the candidate’s experience, regulatory expertise, technical skills, location, and interview performance.
Work Location
Primary Location: India – Remote
Additional Location: Bengaluru, Karnataka
Work Mode: Remote
This position provides an opportunity to work with global clients while collaborating with regulatory professionals and cross-functional teams from a remote working environment.
Career Opportunity
This role offers experienced Regulatory Affairs professionals an opportunity to work on global regulatory consulting projects and gain exposure to multiple products, therapeutic areas, and European regulatory procedures.
The position can provide further career development in areas such as:
- Regulatory Strategy
- Global Regulatory Affairs
- CMC Regulatory Affairs
- Regulatory Lifecycle Management
- Post-Approval Submissions
- Regulatory Consulting
- European Regulatory Affairs
How to Apply
Interested and eligible candidates can apply online through Parexel’s official careers portal.
Candidates should ensure their resume clearly highlights:
- 3+ years of Regulatory Affairs experience
- European post-approval regulatory experience
- CP, MRP, DCP, or National Procedure experience
- Module 3 and CMC expertise
- Veeva RIMS experience
- TrackWise experience
- Regulatory Impact Assessments
- Dossier lifecycle management
Frequently Asked Questions (FAQs)
What is the job role at Parexel?
Parexel is hiring for the position of Regulatory Affairs Associate.
How much experience is required?
Candidates should have at least 3 years of relevant experience in post-approval Regulatory Affairs.
Is this a remote job?
Yes. The primary work location is India – Remote, with Bengaluru listed as an additional location.
What regulatory procedures are relevant to this role?
Experience with European procedures such as CP, MRP, DCP, and National Procedures is required.
What is Module 3 in this role?
Module 3 refers to the Quality/CMC section of the CTD dossier, covering pharmaceutical quality and manufacturing information.
Which regulatory systems are mentioned?
The role specifically mentions TrackWise for change controls and Veeva RIMS for regulatory change and lifecycle management.
