1 Cbe 0 Jobs

Setup a job Alert
JobPe aggregates results for easy application access, but you actually apply on the job portal directly.

Aurobindo Pharma logo
Regulatory Affairs CMC (US Market) Aurobindo Pharma

6.0 - 10.0 years

6 - 14 Lacs

hyderabad

Work from Office

Role & responsibilities Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response. Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports, Review key regul...

Posted 1 month ago

AI Match Score
Apply
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Google Play App Store

Featured Companies

View All Companies