Purpose:

• Support product registration, approvals, and regulatory maintenance activities.
• Ensure compliance with regulatory standards across operations, production, marketing, quality assurance, and patient safety.
• Provide technical, scientific, and marketing expertise.
• Monitor and communicate regulatory updates to facilitate strategic planning and compliance.

Key Responsibilities:

• Assist with submissions and approvals for new products, variations, clinical trials, and renewals.
• Conduct due diligence on regulatory documents and ensure timely applications.
• Maintain strong relationships with internal teams and external stakeholders.
• Monitor and share regulatory requirements and intelligence.
• Update and maintain regulatory databases and dashboards.
• Ensure compliance with global and local regulatory processes and KPIs.
• Provide technical support to Medical, Market Access, Supply Chain, Marketing, and QA teams.
• Review and approve marketing materials for compliance.
• Respond promptly to regulatory inquiries and non-compliance issues.

Requirements

• Key Performance Indicators:
• Timely submissions and approvals for product registrations and variations.
• Strong stakeholder relationships and proactive regulatory communication.
• Compliance with regulatory and organizational standards.

Qualifications:

• Education: B.Pharm or a degree in life sciences.
• Experience: 1-3 years in pharmaceutical regulatory affairs, with knowledge of East and Southern Africa regulatory requirements.
• Skills: Analytical, detail-oriented, organized, strong communication and interpersonal skills.
• Languages: Fluency in English; Portuguese or French is a plus.