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Job Location | Gurugram |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | IT - Software |
Functional Area | Sales / BD,Finance / Accounts / Tax |
EmploymentType | Full-time |
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 updationsTECHNICAL 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.,
Keyskills :
salesmisaccountstatbankinglife cyclemaintenance activitiescmcadherenceownershipinnovationevaluationmaintenancesupplementscommunicationAnnual MeetingsPrint Collateralannual repregulatAnnual Revie