Aurobindo Pharma Limited is one of India’s leading pharmaceutical companies, recognized globally for its robust product p inortfolio and manufacturing capabilities
Requirement Details
Job Title : Regulatory Affairs (Formulations)
Experience :2-4yrs in US Regulatory Affairs
Work
Location :APRCI -Hyderabad, Telangana – 500090
Skills & Competencies :
Computer Knowledge/ eCTD software knowledge
Good knowledge in ICH & FDA guidelines
Experience Required
•Preparation, review & compilation of assigned ANDA/NDA [505 b(2)/projects for fling
•Knowledge of eCTD, Module 2 & 3
•Hands on experience in reviewing CMC documents of Solid & Liquid oral dosage forms
•Review of Pharmaceutical Development Reports (PDR), Manufacturing & analytical documents
Contact Details
Interested candidates can send their profiles to [email protected]
