Jamp Pharma Hiring Details
1) Department: Regulatory Affairs
Position: Assistant Manager / Deputy Manager
Experience: 6-12 yrs
Qualification: B.Pharma / M.Pharma
Location: Ahmedabad
Key Roles:
• Review quality Dossiers in CTD format for new Generic drug submissions, in-line with the guidance and templates.
• Compile responses to deficiencies letters for the given portfolio of products.
• Compile and review the Quality Overall Summary, Module 1 and Module 3 of all planned submissions.
• 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.
• Manage a team of Associates on the day to day functioning of the assigned roles.
• Provide leadership and mentoring to the Team Leads and Associates.
• Prepare and submit due diligence reports of proposed dossiers to Senior Management in India and Canada.
• Hands on experience in MS office (Word, Excel, PowerPoint).
Domain Knowledge:
Candidates having exposure in Dossier compilation and review for Australia market is mandatory and experience of US/Europe/Canada market will be added advantage.
Send profile at sjani@jamppharma.com
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| Jamp Pharma Hiring For Regulatory Affairs Dept |
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