Regulatory Affairs Pharmacist - MSN Laboratories



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Job Responsibilities:

  • Expertise in regulatory norms of Ghana.
  • Prior experience working with Ghana-FDA
  • Thorough knowledge of the dossier & its contents
  • Coordinating & submitting new registration, renewal and variation dossiers
  • Assist the In-House Regulatory team in addressing the queries raised by Regulatory Agencies.
  • Coordinating & preparing of Hospital formulary dossiers
  • Submission of tender documents, samples and the final tenders to the relevant organization
  • Fastracking & Ensuring the timely obtaining of registrations
  • Review regulatory guidelines and update the Head office on the new requirement changes
  • Coordinate GMP application and follow up for site inspections and issuance of cGMP certificates
  • Assist in developing labelling content compliant with regional requirements, ensuring accuracy and consistency & compliance across multiple markets
  • Review marketing materials for accuracy and compliance with applicable regulations, minimizing legal exposure for the company
  • Establishing strong relationships with key stakeholders at regulatory agencies & fostering open communication channels for prompt issue resolution
  • Maintaining contacts and sharing relevant information with relevant disciplines, internally and externally, nationally, and internationally
  • Report ADRs and other pharmacovigilance reporting tools from principals to the regulatory bodies


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Qualifications:

  • Must be a registered Pharmacist in Ghana
  • Proven track record of successful regulatory filings & Registrations
  • Min. 3 years of experience in Regulatory filings
  • Prior experience of IRIMS (Regulatory Data Base) handling


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