Jamp Pharma Ltd Job Vacancy for B Pharma/ M Pharma
REGULATORY AFFAIRS
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
إرسال تعليق