Job Responsibilities for Regulatory Affairs:
 Knowledge of ICH guidelines, CTD dossiers.  Assist in preparing and compiling necessary documents for regulatory
submissions.  Coordination with manufacturer for collecting documents for preparation of
dossier, review of dossier and submission to respective regulatory authority
 Coordinate with the manufacturer to gather necessary information for
submission processes.  Follow-up with manufacturing site for register sample, working standard &
impurity requirement for lab analysis.  To prepare monthly regulatory status report and status of current
registration/Re-registration/post approval changes.  Review of artwork and pack insert as per rules laid by respective regulatory
authority.  Maintain accurate and up-to-date regulatory documentation
 B. Pharm or M. Pharm with at least 2-3 Years of Experience working in
reputed Pharma Company for CIS region is preferable.

📌 Regulatory Affairs-Andheri east (Mumbai)
🏢 Sunrise Consultancy
📍 Mumbai