Regulatory Affairs Executive

0 years

0 Lacs

Posted:1 week ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Company

About Us

About the Role


A Regulatory Affairs Executive for the Africa market plays a critical role in ensuring products comply with regional regulations and maintaining market access across diverse countries. This position requires a blend of technical expertise, communication, project management, and analytical skills to navigate the complex regulatory landscape in Africa


Responsibilities


  • Preparation and submission of registration and re-registration dossiers as per country requirements i.e. African countries, FWA countries and Nepal
  • Submission of various original documents for notarization, chamberization and legalization which forms an important part of dossier.
  • Arrangement for Indent of Samples, Packing Material specimen, Impurities, Reference Standards as per MOH requirement.
  • Establish Coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame.
  • Post approval activities: Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline.
  • Preparation of COPP's (Certificate of Pharmaceutical Product) and FSC to be submitted to Local FDA approvals.
  • Preparation of Tender documents.
  • Enhance self-awareness about changing regulatory requirements.


Qualifications


M. Pharma/B.Pharma


Required Skills


Having experience in Pharmaceutical Industries in African Market

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Cadila Pharmaceuticals Limited logo
Cadila Pharmaceuticals Limited

Pharmaceuticals

Ahmedabad

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