AUROBINDO PHARMA LTD is a growing Indian multinational pharmaceutical manufacturing firm with turnover of over USD 2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations.
Post : Sr.Manager/AGM - Regulatory Affairs of API-R&D Division
Educational Qualification : Ph.D/M.Sc-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 timeh 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
Interested candidates may please send their resume to vinay.bura@aurobindo.com
Shortlisted profiles will receive a call within a week
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