The JAMP group is a proud Canadian owned company with its international headquarters located in Boucherville, 20 minutes from downtown Montreal, Quebec, Canada. The JAMP Pharma Group is active in all sectors of the pharmaceutical industry with our JAMP Pharma Generics, Orimed branded products, our Wampole and Laboratoire Suisse natural health supplements and our Cosmetic Import beauty and personal care products. The JAMP Pharma Group has also made a major investment in biosimilars which is one of the fastest growing markets in the pharmaceutical industry.
Post : Regulatory Affairs (Australia Market) Assistant Manager / Deputy Manager
Key Responsibilities
• Review quality Dossiers in CTD format (Module 1, QOS and Module 3) for new Generic drug submissions, in-line with the guidance and templates for Australia and/or Canada market.
• Compile responses to deficiencies letters for the given portfolio of products.
• Working closely with cross functional teams within the organization and third party teams and maintain good collaboration with all stakeholders CFT for the ongoing projects.
• Provide leadership and mentoring to the Team Leads and Associates.
• Prepare and submit due diligence reports of proposed dossiers.
Department : Regulatory Affairs (Australia Market)
Experience : 6-12 years
Qualification : M.Pharm, B.Pharm
Location : Ahmedabad
Send profile at sjani@jamppharma.com
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