Posted 09 July, 2026
Sr. Executive/AM -Regulatory Affair-ROW Market
Talental Consultings
Hyderabad, TG, IN
Full Time
Reference: 6e1ffc2f25300f66
Job Description
Position :-Regulatory Affairs -ROW Market (Formulation)
\n Roles & Responsibilities : \n
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\n Roles & Responsibilities : \n
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- Preparation, Compilation and Review of dossiers in CTD/country specific format for ASIA or LATAM or AFRICA or MENA & CIS Regions. \n
- 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. \n
- Manufacturing Site GMP Inspection supports with Customers & Cross Functional Departments. \n
- Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. \n
- Participating in calls with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. \n
- Responding to queries with in the time lines received from client/agency. \n
- Preparation of check list as per country specific requirements. \n
- Review of documents like Specifications/MFC/BMR/PV/Stability/PDR/DMF/CoAs/Artworks and other quality related documents for their suitability for registration. \n
- Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. \n
- Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. \n
- Identifying gaps in approved dossier compiled and submit the post approval changes (Minor variations) to agent/agency. \n
- Filing of variations if any and registration renewals. \n
- Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. \n
- Maintaining the product status (Registered and under registration) in excel sheet. \n
