Qureos Mentor

Cadila Pharmaceuticals Limited

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 We&rsquo;re Hiring!
 
 
 
 
 
 Career Opportunity at Cadila Pharmaceuticals Ltd. &ndash; Dholka Plant, Near Ahmedabad
 
 
 
 
 
 Position: Manager
 
 
 Department: Regulatory Affairs - MENA, South Africa, Latin America Region
 
 
 Experience: 8-12 Years Experience
 
 
 Qualification: M. Pharma
 
 
 Location: Dholka, Ahmedabad, Gujarat
 
 
 Cadila Pharmaceuticals Limited
 
 
 
 
 
 About the Role
 
 
 
 
 
 Planning of Dossier and maintaining the client&rsquo;s product portfolio, update guideline and renewal calendar for MENA region.
 
 
 
 
 
 Compilation, review and submission of registration dossiers in the regions of, MENA, South Africa, Latin America Region.
 
 
 
 
 
 Handling of regulatory queries/deficiencies across all the South Africa, MENA, Latin America (Region VI) countries.
 
 
 
 
 
 Submission of Supplements/Variations across all the MENA countries, South Africa, Latin America region also.
 
 
 
 
 
 Review of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols etc. and initiation of Change Controls &amp; Deviations.
 
 
 
 
 
 Ensure availability of current guidelines for Region VI (South Africa, MENA, LATAM,).
 
 
 
 
 
 Arrangement of Samples, Packing Material, Impurities, Reference Standards as per MOH requirement.
 
 
 
 
 
 Any other assignments as specified by the reporting authority from time to time
 
 
 
 
 
 To maintain country wise and product wise registration status for Region VI (South Africa, MENA, LATAM).
 
 
 
 
 
 Creation and Maintenance of Regulatory Database for all the submissions.
 
 
 
 
 
 Establish co-ordination with other departments like QA/QC, R&amp;D, Marketing and Purchase for ensuring the filings and query response within time frame.
 
 
 
 
 
 Preparation of COPP&rsquo;s (Certificate of Pharmaceutical Product) and FSC for submission to FDA approvals.Submission of various original documents for notarization, chamberization and legalization which forms an important part of the dossier.
 
 
 
 
 
 Interested Candidate apply on: savitri.thakor@cadilapharma.com
 
 
 
 
 
 Bhadresh H Khamar Pavankumar Tiwari JAY SHAH Drashti Chaudhari Bhumika Nagar Sanjay Makwana Jimit Sharma Shardulsinh Kathawadia Sharad Yadav
 
 
 
 
 
 
 #Regulatoryaffairs
 
 
 #RA
 
 
 #US
 
 
 #Mena
 
 
 #latam
 
 
 #southafrica
 
 
 #Cadila
 
 
 #job
 
 
 #opportunity
 
 
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Manager

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 Responsibilities
 
 
 <ul>
 <li>
 &middot; To ensure Registration dossier submission of products in different Africa countries (Region I) as per agreed timeline.
 </li>
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 To ensure Renewal of registered product prior to validity expiration of Africa countries (Region I).
 </li>
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 To Review Registration and Re-registration dossiers before submission in all Africa countries (Region I)
 </li>
 <li>
 To maintain country-wise registered product status for all Africa countries (Region I)
 </li>
 <li>
 To co-ordinate with other departments R&amp;D, QA and QC for ensuring the filings &amp; query responses.
 </li>
 <li>
 To provide technical support to team for preparation of Registration/Re-registration dossiers and query responses.
 </li>
 <li>
 To prepare documents for variation filings as and when required for all Africa countries (Region I) &middot;
 </li>
 <li>
 To update registration information in SAP &amp; Cadinet for Africa countries (Region I)
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 To clear issues of commercial Order related to regulatory department for Africa countries (Region I)
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 To review the tender requirements and extend necessary support by providing the required documents and samples.
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 To co-ordinate with International country managers for smooth scheduling the registration activity.
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 </ul>
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 M. Pharma
 </li>
 </ul>
 
 
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Assistant General Manager

Join Cadila Pharmaceuticals Limited and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Cadila Pharmaceuticals Limited

ABOUT_COMPANY

Manager

Assistant General Manager