Africa Regulatory Affairs Professional

2 weeks ago


Dholka, Gujarat, India beBeeRegulatory Full time ₹ 5,00,000 - ₹ 10,00,000

Africa Regulatory Specialist plays a pivotal role in ensuring products adhere to 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.

Key Responsibilities:

  • Preparation and submission of registration dossiers as per country requirements.
  • Submission of various original documents for notarization, chamberization, and legalization.
  • Arrangement for Indent of Samples, Packing Material specimen, Impurities, Reference Standards as per MOH requirement.
  • Establish Coordination with QA/QC, R&D, Marketing, and Purchase departments for ensuring filings and query response within time frames.
  • Post-approval activities: Submission of variations to marketing authorizations for finished products as per respective variation guidelines.
  • Preparation of Certificate of Pharmaceutical Product (COPP) and Foreign Supplier Verification (FSVP) to be submitted to Local FDA approvals.
  • Preparation of Tender documents.
  • Maintaining awareness about changing regulatory requirements.

Qualifications

M. Pharma/B.Pharma required.

Essential Skills:

Proven experience in Pharmaceutical Industries, particularly in the African Market.



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