After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times. Our legacy of over 70 years in healthcare and being dedicated to life in all its dimensions is reaffirmed in our new mission, vision and purpose. Unifying ourselves under the Zydus name, Cadila Healthcare Ltd., is renamed as Zydus Lifesciences Ltd.
Post : Associate Manager / Manager - Regulatory Affairs
Job Description
• Preparation and review of high-quality Drug Master File and certificate of suitability application (CEP) for Active Pharmaceutical Ingredients for submission to USFDA, European, and Rest – Of – World regulatory authorities per current regulatory requirement.
• To file amendments and deficiency response within timelines with go getter approach.
• The job requires review of documents related to DMF submission against predefined checklists and submission to various agencies globally.
• Should keep the all the regulatory database up to date. Candidate must possess “do it right the first-time approach” with proven track record.
• Should keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Candidate should have good communication skills, email etiquettes and must be first class pass out throughout the academic carrier.
• Should be energetic, determined to be successful, and able to deal with new or difficult situations easily.
Additional Information
Experience : 11 years - 15 years
Location : Vadodara, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th November 2024
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