Opportunity for M.Pharm, MSc in Regulatory Affairs at Apotex Inc
Post : Associate / Sr. Associate Labeling – Regulatory Affairs
• 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 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.
Experience : 4-7 years
Qualification : BSc, B.Pharm, MSc, M.Pharma
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
End Date : 15th September, 2020
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube