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 : Associate/Sr. Associate Labeling - Regulatory Affairs
Job Responsibilities
• Responsible for coordination & preparation of Canada and US Packaging components for new product submissions and post approval submissions.
• Develop & maintain regulatory knowledge of Canada &US regulations
• Post approval product life cycle management.
Candidate
• A candidate should preferably be in possession of a BSc/MSc in Biology or Degree/PG in pharmacy and have minimum experience of 2-7 Years in good reputed company.
• Good basic exposure in Canada and US Text of Artwork, Packaging Insert or Outsert and Medication guide preparation and review.
• Good basic knowledge of the solid oral dosage formulations and through understanding of ICH, USFDA, Canada labeling guidelines and requirements.
• Good In English oral and written communication.
Additional Information
Qualification : M.Pharm, B.Sc, B.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 15th November, 2018
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