Regulatory affairs

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.

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. 

High level of expertise in the lifecycle management of radiopharmaceutical products, including CMC authoring, safety labelling experience, artworks annotations

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

Leben Life Sciences Pvt. Ltd. is an established pharmaceutical formulation company for more than four decades. M.Pharm freshers can apply for Apprentice