Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year.
Post : Trainee - Global Regulatory Affairs
Job Description
• eCTD/Technical data compilations and timely submissions for drug product registration of Post applications with regulatory authorities of US, Europe, Canada and Australian Market and updation of RIMS as and when variation filing completes
• Responding to related queries received from regulatory body
• Review of all technical documentsrequired for compiling the submissions, for filing post approval variation (submissions) and query responses
• Review and Support to the Annual Product Quality Review reports and Quality product files
• Review of change control forms
• Relevant communication and follow ups with the respective departments required for compilation, submission and respective query responses
• RIMS updating as and when submissions and variations filing completes
• Adherence to the other responsibilities as assigned by Senior Manager – Regulatory Affairs
• Provides regulatory support to internal functional departments and product development teams
Candidate Profile
Post graduate pharmacy with 0-3 years of experience.
Preferred experience in pharmaceutical with drug development and submission
Additional Information
Qualification : M.Pharm
Experience : 0-3
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global Regulatory Affairs
End Date : 30th May, 2019
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