Natco Pharma Limited- Openings for Regulatory Affairs Department -Apply Now

Job Description

Greetings from Natco Pharma Limited !!

Vacancy for our Regulatory Affairs Department (API) for our API R&D Centre @ Sanath Nagar, Hyderabad.
Education: M.Sc (Organic Chemistry)
Experience: 3-6 years
(Preferable Male Candidates)

JD:

•Coordination with cross functional teams for the deficiencies which are received from various regulatory agencies & ensuring responses are submitted for a speed in approval.
•Evaluation of KSM and vendor documents.
•Complete submissions to FDA, EU regulatory entities.
•Create and maintain product EU technical files.
•Preparation of organized and scientifically valid DMF/Dossier submission to various agencies as per requirement.
•Assessing and filing amendments/variations to the information (which may be related to manufacturing, control, stability studies etc) in DMF/ASMF/Dossier of particular API with the Regulatory agencies.
•ROS evolution of starting material, intermediates and drug substances.
•Involve in the designing of specification for staring material, Intermediates and drug substances.

Interested Candidates are requested to share the profile to Mail ID: jhansi@natcopharma.co.in

Natco Pharma Limited- Openings for Regulatory Affairs Department -Apply Now