Regulatory Affairs Associate (CMC) – Parexel | Remote Option

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Regulatory Affairs Associate (CMC) 

Parexel

Bengaluru / Hyderabad

Remote Option

2–6 Years

EU Regulatory Affairs

Full-Time

🏢 About Parexel

Parexel is a global CRO dedicated to improving global health through regulatory excellence, clinical development, and patient-focused innovation.

📌 Job Overview

• Role: Regulatory Affairs Associate (CMC)
• Location: Bengaluru / Hyderabad
• Work Mode: Onsite & Remote Options
• Experience Required: 2–6 Years
• Shift: EU Working Hours
• Domain: EU Regulatory Submissions & Lifecycle Management

🔬 Key Responsibilities

• Provide regulatory input on CMC documentation
• Support submission delivery strategy & planning
• Author & update dossier sections for MAA lifecycle
• Manage EU post-approval lifecycle activities
• Review & submit dossiers to Health Authorities
• Respond to HA queries & regulatory procedures
• Coordinate with cross-functional global teams
• Support regulatory compliance & documentation updates

🎓 Qualifications & Experience

• M.Pharm / B.Pharm / MSc (Life Sciences, Chemistry, Biotechnology)
• Experience in Regulatory Affairs – CMC
• Knowledge of EU regulatory procedures
• Experience with MAA lifecycle management
• Understanding of change evaluation guidelines
• Willingness to work in EU shifts

🌟 Preferred Skills

• EU lifecycle activity management
• Health Authority interaction experience
• Dossier authoring & regulatory documentation
• Cross-functional collaboration

💼 Salary (Estimated)

₹6 – ₹12 LPA

⭐ Why Join Parexel?

• Work on global EU regulatory submissions
• Remote work flexibility
• Career growth in Regulatory Affairs CMC
• Collaborative & international work environment

📌 Note Before You Apply:
Professionals with EU regulatory submissions and lifecycle management experience will have a strong advantage.

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