October 2026

Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.

This role supports drug substance and drug product development by executing characterization studies. The role involves performing and analyzing advanced analytical testing to assess critical quality attributes and support formulation development, stability studies, and regulatory submissions.

Analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.

Responsible for the design, planning, operation and monitoring of the downstream group and this for development activities as well as for scale-up and GMP production 

Schedule and assign projects to Regulatory Affairs team to ensure business timelines are met. Review, compile and dispatch new product submissions and pre-launch variations. 

M.Sc - Microbiology / Biotechnology / B.E / B.Tech (Biotechnology), USV IS HIRING for Drug Substance Biologics Manufacturing Plant

BA / BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS / PhD /PharmD ) with at least 2 years clinical trial experience.

Exposure to regulatory requirements in healthcare and life sciences, delivering guidance to ensure organizations meet necessary standards.

The 2026 Nobel Prize in Physiology or Medicine has been awarded jointly to Karl Deisseroth, Peter Hegemann and Georg Nagel for their discoveries concerning light-gated ion channels and optogenetics, a breakthrough that has transformed the study of nerve cells and brain function.