NATCO PHARMA LIMITED – Vacancy for Regulatory Affairs Department (API)

 

Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). Our focus is primarily on niche therapeutic areas and complex products. We market and distribute our products in over 40 countries.

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 yrs

(Preferable Male Candidates)

• 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 manufacture, control, stability studies etc) in DMF/ASMF/Dossier of particular API with the Regulatory agencies
• ROS evolution of starting material, intermediate and drug substances.
• Involve in the designing of specification for starting material, Intermediates and drug substances

Interested candidates are requested to share the profiles to Mail id: jhansi@natcopharma.co.in