Regulatory Compliance Specialist

19 hours ago


Dholka, Gujarat, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 13,00,000
Regulatory Compliance Specialist

A critical role exists for a Regulatory Compliance Specialist to ensure product compliance with regional regulations and maintain market access across diverse countries in Africa.

Key Responsibilities:
  • Prepare and submit registration and re-registration dossiers as per country requirements.
  • Arrange for samples, packing materials, impurities, and reference standards according to MOH requirements.
  • Coordinate with QA/QC, R&D, Marketing, and Purchase departments for timely filings and query responses.
  • Submit variations to marketing authorizations for finished products and prepare COPPs (Certificate of Pharmaceutical Product) and FSCs for Local FDA approvals.
  • Enhance self-awareness about changing regulatory requirements.
Qualifications:
  • M. Pharma/B.Pharma degree.
  • Experience in the Pharmaceutical Industry in African markets.
Required Skills:

Strong technical expertise, communication skills, project management abilities, and analytical thinking.



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