Regulatory Affairs Manager - International

Job Description

The Regulatory Affairs Manager will lead all regulatory activities to ensure timely registration, compliance, and maintenance of the company’s pharmaceutical products in Zimbabwe and within the SADC region. The role requires strong liaison with regulatory authorities, cross-functional collaboration, and deep knowledge of pharmaceutical legislation. The manager will represent the client company in all regulatory matters while ensuring that all operations comply with local and international standards.

Key Responsibilities

• Regulatory Strategy & Compliance

• Develop and implement regulatory strategies to support product registration, renewals, variations, and market expansion.
• Ensure full compliance with MCAZ (Medicines Control Authority of Zimbabwe) regulations, SADC guidelines, WHO standards, and global corporate policies.
• Monitor changes in regulatory frameworks and advise internal stakeholders on impact and required actions.

• Regulatory Submissions & Documentation

• Prepare, review, and submit high‑quality dossiers for new product applications, line extensions, renewals, and post‑approval variations.
• Maintain up‑to‑date regulatory records, product registration certificates, and compliance documentation.
• Ensure product artwork, labeling, PILs, and packaging materials comply with MCAZ requirements.

• Authority Engagement & External Relations

• Serve as the primary contact point for MCAZ and other governmental bodies.
• Facilitate inspections, audits, and regulatory reviews, ensuring corrective actions are implemented.
• Participate in industry forums, regulatory workshops, and GMP-related engagements.

• Cross-Functional Collaboration

• Work closely with Quality Assurance, Medical Affairs, Supply Chain, and Commercial teams to ensure regulatory compliance across the product lifecycle.
• Provide regulatory input for product launches, promotional materials, and scientific communications.

• Risk Management & Reporting

• Identify compliance risks and implement mitigation plans.
• Prepare regulatory performance reports and compliance metrics for senior management.
• Lead internal regulatory training sessions to strengthen organisational compliance culture.

Qualifications & Experience

• Academic Requirements

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biochemistry, or related field (mandatory).
• Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, Public Health, or Quality Management (advantageous).

• Professional Experience

• Minimum 5 years’ experiencein regulatory affairs within the pharmaceutical industry.
• Proven track record of managing regulatory submissions and interacting with MCAZ or similar regulatory bodies.
• Experience working with multinational pharmaceutical companies strongly preferred.

• Technical Skills

• Strong understanding of MCAZ registration processes, SADC regulatory environment, GMP, GDP, and pharmacovigilance frameworks.
• Proficiency in CTD dossier preparation and electronic submission systems.
• Exceptional documentation and compliance management skills.

• Core Competencies

• Excellent communication and stakeholder management abilities.
• High attention to detail and strong analytical capability.
• Ability to work cross‑functionally and manage multiple projects simultaneously.
• Ethical, proactive, and highly professional approach to regulatory compliance.

Remuneration & Benefits

A competitive remuneration package will be offered, aligned with experience and multinational pharmaceutical industry standards. Additional benefits may include medical cover, performance bonuses, professional development support, and regional exposure.