Parexel Hiring Regulatory Affairs Associate in India | Hyderabad, Bengaluru & Remote Opportunities
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(Parexel Hiring Regulatory Affairs Associate in India) |
Introduction
Regulatory Affairs continues to be one of the most important and rapidly growing functions within the pharmaceutical and life sciences industry. Professionals with expertise in regulatory submissions, CMC documentation, lifecycle management, and global regulatory compliance are increasingly in demand across pharmaceutical companies, CROs, and biotechnology organizations.
Parexel, a globally recognized clinical research and regulatory consulting organization, has announced a new opportunity for the position of Regulatory Affairs Associate in India. The role is available in Hyderabad, Bengaluru, and remote work locations, offering experienced regulatory professionals an opportunity to contribute to post-approval regulatory activities, CMC lifecycle management, regulatory impact assessments, and European regulatory procedures.
Candidates with experience in CTD Module 3, Veeva RIMS, TrackWise, CMC documentation, and EU regulatory submissions are encouraged to explore this career opportunity.
About Parexel
Parexel is one of the world's leading clinical research organizations (CROs), providing comprehensive services in clinical development, regulatory consulting, pharmacovigilance, market access, and commercialization support.
Founded in 1982, Parexel is headquartered in Durham, North Carolina, United States. The company operates in more than 50 countries and employs approximately 20,000+ professionals worldwide.
Parexel supports pharmaceutical, biotechnology, and medical device companies throughout the product lifecycle, helping them navigate complex regulatory requirements and accelerate the delivery of innovative therapies to patients worldwide.
The company is particularly known for its expertise in Regulatory Affairs, Clinical Research, Medical Writing, Pharmacovigilance, and Quality Compliance services.
Job Overview Summary
Parexel is seeking experienced Regulatory Affairs professionals to support post-approval regulatory activities for medicinal products marketed through various European regulatory pathways.
The selected candidate will work closely with cross-functional teams to evaluate regulatory changes, maintain regulatory dossiers, update CMC documentation, conduct impact assessments, and ensure compliance with evolving regulatory requirements.
This role is ideal for professionals looking to strengthen their expertise in European Regulatory Affairs, CMC lifecycle management, and post-approval regulatory operations.
Vacancy Details
| Particular |
Details |
| Company |
Parexel |
| Job Role |
Regulatory Affairs Associate |
| Job Requisition ID |
R0000043744 |
| Department |
Regulatory Affairs |
| Employment Type |
Full-Time |
| Locations |
Hyderabad, Hyderabad Remote, Bengaluru, Bengaluru Remote |
| Experience |
3+ Years |
| Industry |
Pharmaceutical / Clinical Research / Life Sciences |
| Functional Area |
Regulatory Affairs |
| Work Mode |
Hybrid / Remote Opportunities Available |
Regulatory Affairs Associate Job Role Explained
The Regulatory Affairs Associate plays a critical role in maintaining compliance throughout the lifecycle of approved pharmaceutical products.
The professional will evaluate regulatory impacts associated with manufacturing changes, product updates, labeling modifications, and quality-related changes. They will help maintain regulatory dossiers and support marketing authorization maintenance activities across European markets.
Key responsibilities may include:
Regulatory Impact Assessments
Review proposed manufacturing and product changes and determine their regulatory implications.
CMC Documentation Management
Maintain and update Chemistry, Manufacturing and Controls (CMC) documentation to ensure compliance with regulatory expectations.
CTD Module 3 Updates
Prepare, review, and revise CTD Module 3 documentation as part of post-approval lifecycle management activities.
Regulatory Lifecycle Management
Support ongoing maintenance of approved products through variation submissions and regulatory updates.
Documentation Gap Analysis
Identify missing or outdated information within regulatory dossiers and recommend corrective actions.
Cross-Functional Collaboration
Coordinate with manufacturing, quality assurance, supply chain, and regulatory teams to ensure successful implementation of regulatory strategies.
Eligibility Criteria
Applicants should possess:
- Degree in Pharmacy
- Pharmaceutical Sciences
- Life Sciences
- Chemistry
- Or a related scientific discipline
Experience Requirements:
- Minimum 3 years of Regulatory Affairs experience
- Experience in Post-Approval Regulatory Affairs
- Knowledge of CMC documentation
- Understanding of CTD Module 3
- Experience with EU regulatory procedures
- Regulatory lifecycle management experience preferred
Skills Required
Successful candidates should possess strong knowledge in:
- Regulatory Affairs
- CMC Documentation
- CTD Module 3
- Regulatory Impact Assessment
- Veeva RIMS
- TrackWise
- Post-Approval Variations
- Lifecycle Management
- Change Control Management
- Gap Analysis
- Marketing Authorization Maintenance
- CP, MRP, DCP Procedures
- EU Regulatory Affairs
- Pharmaceutical Compliance
- Documentation Management
- Scientific Writing
- Cross-Functional Communication
- Analytical Thinking
These skills are highly valued across pharmaceutical companies, CROs, and global regulatory consulting organizations.
Expected Salary
Parexel has not officially disclosed the compensation package for this role.
Based on current market trends for Regulatory Affairs professionals in India:
Estimated Salary Range
₹6,00,000 – ₹12,00,000 per annum
Actual compensation may vary depending on:
- Total experience
- Regulatory expertise
- Technical skills
- Interview performance
- Internal company compensation policies
- Location
Interview Details
Parexel has not released specific interview schedules for this position.
Typically, the hiring process may include:
- Resume Screening
- HR Discussion
- Technical Regulatory Affairs Interview
- Managerial Discussion
- Final Selection
Candidates should regularly monitor their email for interview communications.
Required Documents
Candidates should keep the following documents ready before applying:
- Updated Resume/CV
- Educational Certificates
- Degree Certificates
- Government Identity Proof
- Experience Certificates
- Current CTC Details
- Recent Salary Slips
- Notice Period Details
- Regulatory Affairs Project Experience Documentation
- Professional Certifications (if applicable)
Providing accurate documentation can help streamline the recruitment process.
How to Apply
Interested candidates can apply directly through the official Parexel careers portal:
Application Link:
Candidates are advised to carefully review all eligibility requirements before submitting their applications.
Frequently Asked Questions (FAQs)
Is this a remote Regulatory Affairs job?
Yes. Parexel has listed both office-based and remote opportunities for Hyderabad and Bengaluru locations.
What experience is required?
Candidates should ideally possess 3+ years of relevant Regulatory Affairs experience.
Is experience in CTD Module 3 necessary?
Yes. Experience with CTD Module 3 and CMC documentation is highly relevant for this role.
Which regulatory procedures should candidates know?
Knowledge of Centralised Procedure (CP), Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP), and National Procedures is preferred.
Is this role suitable for freshers?
No. The role requires prior Regulatory Affairs experience and is not intended for fresh graduates.
What software knowledge is preferred?
Candidates with experience in Veeva RIMS and TrackWise will have an advantage.
Final Conclusion
The Parexel Regulatory Affairs Associate opportunity offers an excellent platform for experienced regulatory professionals looking to advance their careers in post-approval regulatory affairs, CMC documentation, and European regulatory compliance.
With exposure to lifecycle management, regulatory impact assessments, CTD Module 3 maintenance, and global pharmaceutical operations, this position provides valuable experience for professionals aiming to build long-term careers in Regulatory Affairs.
Candidates with strong scientific backgrounds and hands-on regulatory experience should consider applying promptly to maximize their chances of securing this opportunity.
Disclaimer
Note: Pharma Duniya does not charge any money for job information. Candidates are advised to verify details from the official company website.
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