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Dy Manager/Manager- Regulatory Affairs- ROW - Formulations

5 - 10 years

7 - 14 Lacs

Hyderabad/Secunderabad

Posted:1 week ago| Platform: Naukri logo

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Skills Required

Regulatory Affairs eCTD Stability BMR PV Europe Africa MFC GMP CoPP Cis Dossiers MENA RA CTD Asia Formulation Latam Artworks RoW DMF PDR Emerging Markets

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. 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. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6. Responding to queries with in the time lines received from client/agency. 7. Preparation of check list as per country specific requirements in RoW region. 8. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in RoW region. 9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. 10. Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. 11. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. 12. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Desired Candidate Profile Should Have Regulatory Affairs Relevant Experience Perks and Benefits

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vbshilpa.com

Pharmaceutical Manufacturing

RAICHUR Karnataka

1001-5000 Employees

8 Jobs

    Key People

  • Mr. Kiran M. Kalavathi

    Managing Director

  • Mr. Vikas B. Shilpa

    Chief Financial Officer

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