Sr. ExecutiveAM Regulatory Affair-ROW Market
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Position :-Regulatory Affairs -ROW Market (Formulation)
Roles & Responsibilities :
- Preparation Compilation and Review of dossiers in CTD/country specific format for ASIA or LATAM or AFRICA or MENA & CIS Regions.
- Co-ordinating with cross functional departments like API R&D QC QA PDD Micro for documents required for dossier compilation for initial submission query responses or other submission like tender activities.
- Manufacturing Site GMP Inspection supports with Customers & Cross Functional Departments.
- Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration.
- Participating in calls with agents/partners for submission of Dossiers and further updates or requirements if any on product registration.
- Responding to queries with in the time lines received from client/agency.
- Preparation of check list as per country specific requirements.
- Review of documents like Specifications/MFC/BMR/PV/Stability/PDR/DMF/CoAs/Artworks and other quality related documents for their suitability for registration.
- Co-ordinating for CoPP GMP License and other required documents/certificates legalization activity required for dossier compilation and registration.
- Archiving/Maintenance of the dossiers renewal files and variation approvals along with supporting documents in regulatory data base.
- Identifying gaps in approved dossier compiled and submit the post approval changes (Minor variations) to agent/agency.
- Filing of variations if any and registration renewals.
- Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments.
- Maintaining the product status (Registered and under registration) in excel sheet.
