Aurobindo Pharma hiring for Regulatory affairs Department

Aurobindo Pharma

Requirement Details

Job Title: Regulatory Affairs (Formulations)

Experience: 2-4yrs in US Regulatory Affairs

Work Location:

APLRC1-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 filing

•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 Hrrc1@aurobindo.com