Regulatory Affairs Associate – Annual Report / Renewals, Biologics

Parexel

Regulatory Affairs Associate handling regulatory applications and procedures across regions. Collaborating with cross-functional teams to ensure compliance and support annual reports/renewals.

Posted 5/16/2026full-timeRemote • 🇮🇳 IndiaJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

Understand the regulatory framework and regional trends for various types of applications
Support Annual reports/Renewals in multiple regions
Liaise with cross-functional members with aligned product responsibilities
Evaluate changes according to country guidelines
Manage lifecycle activities in the EU markets

Requirements

What you’ll need

2 to 4 years of experience in Regulatory Affairs-CMC
Willingness to work in EU Shifts
Knowledge of regulatory framework for applications and procedures for small and large molecules
Support Annual reports/Renewal experience US/ EU/Brazil/LATAM/China
Liaise closely with cross-functional members
Knowledge of change evaluation according to country guidelines
Experience in managing lifecycle activities in the EU markets
Knowledge of CTD guidelines

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Parexel Website LinkedIn All Job Openings 10,000+ employees Founded 1983 ⚕️ Healthcare Insurance 🧬 Biotechnology 💊 Pharmaceuticals 💰 Venture Round on 1990-01 Healthcare Insurance
Biotechnology
Pharmaceuticals Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials. Regulatory Affairs Associate – Annual Report / Renewals, Biologics 🔥 0 minutes ago 🇮🇳 India – Remote ⏰ Full Time 🟢 Junior 🟡 Mid-level 🚔 Compliance 🚫👨‍🎓 No degree required Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Understand the regulatory framework and regional trends for various types of applications
Support Annual reports/Renewals in multiple regions
Liaise with cross-functional members with aligned product responsibilities
Evaluate changes according to country guidelines
Manage lifecycle activities in the EU markets 🎯 Requirements
2 to 4 years of experience in Regulatory Affairs-CMC
Willingness to work in EU Shifts
Knowledge of regulatory framework for applications and procedures for small and large molecules
Support Annual reports/Renewal experience US/ EU/Brazil/LATAM/China
Liaise closely with cross-functional members
Knowledge of change evaluation according to country guidelines
Experience in managing lifecycle activities in the EU markets
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Hard Skills & Tools

Regulatory Affairs-CMCAnnual reportsRenewalsChange evaluationLifecycle activitiesCTD guidelinesRegulatory frameworkProcedures for small moleculesProcedures for large molecules

Soft Skills

Cross-functional collaborationCommunication