Parexel has announced a new opening for a Regulatory Affairs Associate in India. The position is available across Hyderabad and Bengaluru, including remote-location listings, and is suitable for regulatory affairs professionals with experience in post-approval regulatory activities, CMC documentation, CTD Module 3, Veeva RIMS, regulatory impact assessment and EU regulatory procedures.

This Parexel Regulatory Affairs Associate job offers an opportunity to work on lifecycle management of medicinal products registered through European procedures such as Centralised Procedure (CP), Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and National Procedures.

Candidates looking for Regulatory Affairs jobs in Hyderabad, Regulatory Affairs jobs in Bengaluru, CMC Regulatory Affairs jobs, or post-approval regulatory jobs in India can review the eligibility and application details below.

Parexel Regulatory Affairs Associate – Job Overview

About Parexel

Parexel is a global clinical research and biopharmaceutical services organization supporting pharmaceutical and life sciences companies across clinical development, regulatory affairs, consulting and market access.

Through its regulatory services, Parexel supports organizations in navigating complex regulatory requirements and maintaining compliant medicinal product portfolios throughout the product lifecycle.

Key Responsibilities

As a Regulatory Affairs Associate at Parexel, the selected professional will support post-approval regulatory and lifecycle management activities for medicinal products.

Key responsibilities include:

• Perform Regulatory Impact Assessments (RIA) for change controls raised through TrackWise.
• Evaluate the regulatory implications of manufacturing, quality, labeling and product-information changes.
• Manage and maintain regulatory change records using Veeva RIMS.
• Support regulatory strategies for post-approval changes.
• Review, update and author relevant CTD Module 3 sections for medicinal products.
• Maintain current and compliant CMC regulatory documentation.
• Support regulatory dossier lifecycle maintenance across multiple markets.
• Conduct detailed gap analyses of Module 3 documentation.
• Identify regulatory compliance risks, missing information and documentation deficiencies.
• Recommend remediation plans and regulatory strategies for identified gaps.
• Manage post-approval regulatory activities throughout the medicinal product lifecycle.
• Support maintenance of marketing authorizations across European markets.
• Collaborate with quality, manufacturing and other cross-functional stakeholders to meet regulatory commitments.

Qualifications and Experience

Candidates interested in the Parexel Regulatory Affairs Associate vacancy should ideally have:

• A relevant degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry or another related scientific discipline.
• Approximately 3+ years of relevant Regulatory Affairs experience, based on the job description.
• Hands-on understanding of post-approval regulatory activities for medicinal products.
• Knowledge of European regulatory procedures, particularly CP, MRP, DCP and National Procedures.
• Experience with CMC regulatory documentation and CTD Module 3.
• Understanding of regulatory lifecycle management and post-approval changes.
• Experience conducting Regulatory Impact Assessments.
• Familiarity with regulatory information management systems such as Veeva RIMS.
• Familiarity with change-control systems such as TrackWise.
• Strong documentation, analytical and cross-functional communication skills.

Important: The supplied job description emphasizes relevant regulatory experience rather than specifying one mandatory academic degree. Candidates should verify the complete eligibility requirements on Parexel’s official application portal before applying.

Key Skills

Candidates with the following skills may be particularly relevant for this Regulatory Affairs opportunity:

Regulatory Affairs | Post-Approval Regulatory Affairs | CMC | CTD Module 3 | Regulatory Impact Assessment | Veeva RIMS | TrackWise | Lifecycle Management | Gap Analysis | Marketing Authorization Maintenance | CP | MRP | DCP | National Procedures | Change Control | EU Regulatory Affairs

Why Consider This Regulatory Affairs Role?

This opportunity can provide regulatory professionals with exposure to:

• European medicinal product regulatory procedures.
• Post-approval regulatory lifecycle management.
• CMC dossier maintenance and CTD Module 3 activities.
• Regulatory impact assessments and change controls.
• Regulatory information management through Veeva RIMS.
• Cross-functional pharmaceutical regulatory operations.
• Multi-market marketing authorization maintenance.
• Global clinical research and life sciences operations.

Professionals seeking to strengthen their careers in CMC Regulatory Affairs, EU Regulatory Affairs and regulatory lifecycle management may find the scope particularly relevant.

Salary for Parexel Regulatory Affairs Associate

Parexel has not disclosed the salary for this vacancy in the provided job posting.

For structured-data purposes, an estimated market range of ₹6,00,000–₹12,00,000 per year may be used only as a clearly labeled estimate and should not be represented as an officially disclosed Parexel salary.

Actual compensation may vary depending on experience, skills, location, internal compensation structure and other factors.

How to Apply

Application Link