We're Hiring
REGULATORY AFFAIRS
JAMP PHARMA GROUP
Post Approval (Post Commercial)
Key Roles:
• Prepare, submit and defend regulatory submissions for marketed products including SANDs and Annual notifications. • Ensure that submissions are accurate, complete and compliant with the
regulatory requirements.
• Prepare responses to questions raised by Health Canada. • Evaluate proposed changes to marketed products for regulatory impact and liaise with internal/external stakeholders to assemble necessary
documentation.
• Collaborate with product launch team for strategic product launches.
• Provide regulatory support for projects related to the transfer of product manufacturing sites.
• Interact with QA, Drug Development, supply chain teams to fulfil the
regulatory part of change control process. • Ensure the regulatory compliance of completed change controls.
Experience: 8-11 yrs
Qualification: B.Pharm / M.Pharm
Location: Ahmedabad
Department: Regulatory Affairs - Post Approval
(Post Commercial)
Send profile at
praval@jamppharma.com
