🏠💼 Work From Home: Regulatory Affairs Consultant – Biologics @ Parexel

chandrakanth gck July 03, 2025

🌐💊 Join Parexel – Regulatory Affairs Associate / Sr. Associate

🔍 Empowering global healthcare through smarter drug development.

📝💼 Job Description

👤 Position: Regulatory Affairs Associate & Sr. Regulatory Affairs Associate
📍 Location: Remote (India – Bengaluru / Hyderabad)
🆔 Job ID: R0000032362

✅📋 Key Responsibilities

✔️ Regulatory Submissions:
Manage lifecycle maintenance for approved products –
🔄 CMC variations, 🔁 renewals, and 🔃 marketing authorization transfers (EU, ASEAN & regulated markets)

📂 Dossier Review:
🔍 Review EU eCTD and international submissions for regulatory compliance

📬 Health Authority Queries:
🕒 Respond accurately and on-time to questions from regulatory agencies

🤝 Stakeholder Coordination:
Work with 🧑‍💻 internal and 🌐 external teams to ensure timely submissions

🚀 Process Improvement:
🧠 Identify workflow gaps & suggest process enhancements

🎯📌 Eligibility Criteria

🧪 Experience: 3–8 years in Regulatory Affairs (EU submissions preferred)

🧠 Skills:
🔹 Expertise in post-approval changes (EU)
🔹 Experience with RIMS tools (💡 Veeva Vault preferred)
🔹 Knowledge of small molecules & biologics

🎓 Education:
Degree in Pharmacy, Life Sciences, or related field

🌟🙌 Why Join Parexel?

🌍 Global Impact: Deliver life-changing therapies to patients faster
🏡 Remote Flexibility: Work from home (Bengaluru / Hyderabad)
📈 Career Growth: Advance in regulatory strategy, consulting, and leadership
💖 Patient-Centric Culture: Join a mission-driven, compassionate team