Regulatory Affairs Associate (Clinical Trial Application) in Parexel

🚀 Hiring: Regulatory Affairs Associate (Clinical Trial Application)

📍 Location: Remote (India) 
💼 Experience: 2–4 Years 
🧾 Job Type: Full-Time 
🏢 Work Mode: Remote 

🧾 Role Overview:

Parexel is hiring a Regulatory Affairs Associate for a remote India-based role. This is a great opportunity for professionals with experience in clinical trial regulatory submissions, SUGAM portal, and NDCT rules, offering exposure to global regulatory processes and drug development.

🛠️ Key Skills:

✔ Strong knowledge of NDCT Rules (India) 
✔ Experience with SUGAM portal submissions 
✔ Understanding of CTRI registration process 
✔ Knowledge of global regulatory frameworks 
✔ Strong communication and stakeholder management skills 
✔ Ability to work independently and across time zones 

🎯 Key Responsibilities:

✔ Prepare and submit Clinical Trial Applications (CTA/iCTA) via SUGAM portal 
✔ Manage regulatory submissions, amendments, and query responses 
✔ Coordinate with global sponsors and cross-functional teams 
✔ Support documentation for SEC meetings 
✔ Handle CTRI registrations 
✔ Track regulatory updates and Gazette notifications 
✔ Maintain submission timelines and status updates 
✔ Ensure compliance with regulatory guidelines 
✔ Mentor junior team members 

🎓 Required Qualifications:

✔ Bachelor’s or Master’s in Pharmacy, Life Sciences, or related field 
✔ 2–4 years of experience in Regulatory Affairs (Clinical Trials) 


💰 Salary & Benefits:

✔ ₹5 LPA – ₹10 LPA (Estimated) 
✔ Fully remote work flexibility 
✔ Exposure to global clinical trials 
✔ Opportunity to work with a leading CRO 
✔ Strong career growth in regulatory affairs 

💬 Join WhatsApp Group: 
👉 Join Now