Regulatory affairs

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.

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.

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.

Masters in Life Sciences / Biotechnology / Pharma / Management / Health Innovation / Public Policy or any other related area. BIRAC

Plan, track, and deliver submissions aligned with timelines and regulatory requirements. Manage risks, dependencies, and complexities in global regulatory environments.

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.

Fresenius Kabi India is a global healthcare company MNC that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.