Regulatory affairs

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.

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

Regulatory Affairs (Pharmaceuticals & Medical Devices) Quality Management System (QMS)Medical Device Licensing and Compliance 

Perform chemical analysis of raw materials, in-process and products. Stability studies and dissolution testing. Maintain laboratory instruments and documentation as per GMP. 

PhD in any branch of Life Sciences / Agricultural Biotechnology / Food and Nutrition Sciences/ Food Technology or equivalent

Regulatory compliance & query handling. Documentation & record management. Cross-functional coordination