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 [email protected]
