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.
• 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.
• 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
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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