Natco Pharma Limited is hiring 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. Interested and eligible candidates can share resume at jhansi@natcopharma.co.in
Vacancy Details :
- Company Name: Natco Pharma Limited
- Location : Sanath Nagar, Hyderabad
- Post Name: Regulatory Affairs Department (API)
- Qualification: M.Sc. (Organic Chemistry)
- Experience: 3 – 6 years
- No of Vacancies: Details not provide by recruiter
- Details of Salary: Details not provide by recruiter
- Contact: jhansi@natcopharma.co.in
- Mode of application : Online
- Selection Process: Personal interview
Job Description/Skills Required :
Please find the details of opening for our Regulatory Affairs Department (API) Department for our Pharma Division located at Sanath Nagar, Hyderabad..
Job Description :
(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
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