Regulatory affairs

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.

Knowledge about the various types of applications filed on the Online ODLS portal forTelangana and ONDLS portal.

Experience and expertise in authoring, compiling and submission of country specific submissions (MAA,BLA, and post approval changes) of Biologics/Biosimilar products in various markets- Regulated (EU/US/Canada) and emerging markets. 

Scale-up & Exhibit Batches, Tech Transfer (IR/SR/ER), Documentation, Troubleshooting & AN DA Evaluation