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| Education | Not Mentioned |
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| Industry | IT - Software |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
3- 4 years of experience in Regulatory submission for US market Description RESPONSIBILITIES: Ensure timely submission of dossiers in US and Canada. Ensure timely submission of post- approval maintenance activities such as annual reports , labelling and CMC changes , supplements etc. Thorough evaluation of proposed changes. Pharmacoepial updations. Compliance to dossier commitments. Regular tracking of innovator labeling updations. TECHNICAL EXPERIENCE: Thorough knowledge of CMC requirements , labelling requirements , regulatory impact of post approval changes and regulatory life cycle management. PERSONAL ATTRIBUTES: Commitment , ownership , integrity , adherence to time lines. Ability to work with tight time lines. Good communication skills. Proactive problem solving. This site is best viewed with a resolution of 1024x768 (or higher) and supports Microsoft Internet Explorer 8.0+ and Firefox 3.0+ ,
Keyskills :
validation adherence internetexplorer chemistry annualreports ownership lifecycle regulatoryaffairs oncology api management hplc compliancemanagement maintenanceactivities pharma regulatory compliance research firefox mc