DRA

Prepare regulatory dossiers and technical documentation for IVD products. Draft SOPs, validation protocols, stability study protocols, and performance study protocols.

To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.

Manage product registrations, renewals, variations and lifecycle activities. Review SmPC, PIL, artworks, labels and other regulatory documents.

Master Degree in Pharmacy / Forensic Pharmacy with specialization in Pharmacology or concerned/allied/relevant discipline with a very good academic record throughout. two publications in renowned journals of repute UGC -care listed journal/ Web of Science /SCOPUS Indexed journals

Experience into solid oral dosage & liquid orals form in Formulation and development department for regulated market

Scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements.

Knowledge of Injectable plant in Validation of injection filing line, Lyo, Autoclave, DHS etc & Knowledge of QMS 

This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.

B.Pharm, M.Pharm Specialisation in Regulatory Affairs/ Pharmaceutics/Analysis, Quality Assurance at Aurobindo Pharma