ASSOCIATE/SR.
ASSOCIATE LABELING-REGULATORY AFFAIRS @ APOTEX , BSc/MSc / B.Pharm
/ M.pharm.
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.
Job Summary
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.
Job Requirements
- 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.
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