MSN Group Pharmaceutical Jobs in Western Region
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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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