AUROBINDO Hiring Sr.Manager/AGM – Regulatory Affairs of API-R&D Division
Educational Qualification: PhD /MSc – Chemistry
Experience Required: 15-20 years experience in any reputed Organisation
Location : Hyderabad
JOB PROFILE:
- Leading & responsible for smooth functioning of API Regulatory affairs department and timely submission of DMF/ASMF/ CEP in all regions (US/EU/Japan/Canada/ China and ROW)
- Strategizing regulatory support needed for business continuity & extension for API for global markets.
- Preparation and filing of DMFs to regulatory authorities EDQM/EU/US/Canada/Australia authorities in eCTD format.
- Experience in addressing the major deficiencies responses such as re-definition of starting materials, impurities controls, genotoxic concerns, advanced intermediates for different products for specific authorities in the global wide.
Application Process :
Interested candidates may please send their resume to vinay.bura@aurobindo.com
Shortlisted profiles will receive a call within a week.
Aurobindo Regulatory affairs managerial openings 2022 at Hyderabad
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