Regulatory affairs

A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides.

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.

M.Pharm in the relevant specialization Ph.D. in Pharmaceutical Sciences. Applications are invited for faculty roles in the following departments- Pharmaceutics, Pharmaceutical Chemistry, Pharmacology, Pharmacy Practice, Pharmacognosy, Regulatory Affairs

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

M.Sc. / M.Pharm / B.Pharm in Pharmaceutical Analysis, Chemistry, or related discipline. 2-3 years of hands-on HPLC experience is mandatory.

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.

Lead regulatory due diligence and manage global product registrations, renewals, variations, and other regulatory submissions in compliance with timelines.