Regulatory affairs

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

Seeking a highly experienced Regulatory Affairs professional to manage regulatory activities for parenteral (injectable) products across the LATAM region.

Looking for a dedicated and experienced professional to join our Regulatory Affairs team.

This role is pivotal in managing activities pertaining to product lifecycle management, quality management and pharmacovigilance, including variations and renewals, SOP development, risk management, and trainings.

Regulatory Knowledge & Compliance, Communication & Coordination, Analytical & Problem-Solving Abilities.