Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India.
Post : Associate / Sr. Associate Labeling - Regulatory Affairs
Job Description
• 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 Profile
• Candidate should preferably be in possession of a BSc/MSc in Biology or Degree/PG in pharmacy and have minimum experience of 4-7 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
Experience : 4-7 years
Qualification : BSc, B.Pharm, MSc, M.Pharma
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
End Date : 15th September, 2020
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