DRA

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.

Finecure Pharmaceuticals Limited is a leading manufacturer and marketer of Pharmaceutical formulations in several therapeutic segments in dosage forms of Tablets, Capsules, & Dry Powders for Syrup having manufacturing locations at Sanand I Changodar Ahmedabad.

Maintain accurate regulatory fifes, submission records, and product registrations. Ensure documentation it audit-ready and compliant with company procedures. Support internal and external audits as required.

Review and Finalize the preparation of new drug submissions, deficiencies to regulatory letters and post approval activities for the given portfolio of products.

The role involves handling initial submissions, deficiency management, post-approval variations and lifecycle management activities in compliance with global regulatory requirements.

Seeking a highly experienced Regulatory Affairs professional to manage regulatory activities for parenteral (injectable) products across the LATAM region. The role involves end-to-end regulatory lifecycle management, ensuring timely submissions, approvals, and compliance with regional regulatory requirements.

Preparation and control of SOPs, STPs, specifications, formats, and master documents. Review of BMR, BPR, deviations, change controls, and CAPA records. CLAPS Industries require QA Documentation professional