Overview

• The Manager of Registration and Regulatory Compliance for the AFRICA region plays a key leadership role in ensuring regulatory compliance across all countries in scope, while aligning with global corporate standards. This position requires a seasoned regulatory affairs professional with experience managing complex, multi-country environments and leading in diverse, multicultural settings.
• The role demands expertise in regulatory strategy, policy development, and compliance, along with a strong track record of engaging with Ministries of Health, trade associations, and regulatory bodies. The Manager must anticipate legislative changes, influence regulatory frameworks, and align compliance efforts with business goals.
• Success depends on cross-border collaboration, stakeholder influence, and navigating diverse regulatory systems. The role also includes leading a multicultural team, delivering training, and fostering a culture of regulatory excellence. It reports to the AMET Director and is part of the Global Safety Assessment and Regulatory Affairs (GSARA) organization.

Responsibilities:

• Ensure End-to-End Regulatory Compliance: Lead regulatory compliance efforts across Africa to guarantee uninterrupted business operations, aligning with global standards while adapting to local regulatory frameworks and ensuring product availability on shelves.
• Drive Regulatory Strategy and Market Access: Develop and execute proactive regulatory strategies that anticipate legislative changes, reduce registration lead-times through high-quality dossiers, and accelerate market entry to support business growth and market share expansion.
• Leverage Regulatory Expertise for Competitive Advantage: Identify and manage regulatory challenges and opportunities to create business value, enhance operational efficiency, and contribute to commercial success through strategic regulatory positioning.
• Strengthen External Engagement and Advocacy: Build and maintain strong relationships with Ministries of Health, regulatory authorities, and trade associations, expanding external networks and advocating for favorable regulatory environments.
• Lead and Empower a Multicultural Team: Manage a diverse regional team, fostering a culture of regulatory excellence through impactful training programs, continuous improvement, and cross-functional collaboration with business stakeholders.
• Integrate Regulatory with Business Objectives: Ensure timely regulatory assessments and seamless integration with commercial and operational teams, aligning compliance efforts with broader corporate goals across AMET regions.
• Act as Company Pharmacist Representative: Serve as the official company pharmacist representative to health authorities for regulated pharmaceutical products, ensuring compliance with national pharmacy regulations and maintaining professional licensure standards.

Experience you’ll bring:

• Educational Background: Bachelor’s degree in pharmacy (mandatory)
• Professional Experience: Minimum 8 years in Regulatory Affairs within industries such as personal repellents, pesticides, home care, personal care, pharmaceuticals.
• Regulatory Expertise: Solid knowledge of regulatory processes for personal repellents or pharmaceutical products in South Africa. Proven experience in direct engagement with Ministry of Health officials, trade associations, and regulatory advocacy leading to successful policy implementations and strengthened industry relationships.
• Language Proficiency: Fluent in English (written and oral), fluency in French is highly appreciated.
• Strategic Policy Analysis and Development: Ability to understand and interpret legislative and regulatory environments, anticipate policy changes, and develop strategies that align with organizational objectives.
• Regulatory Advocacy: Experience in direct engagement with Ministry of Health officials and trade associations, leading to successful policy implementations and strengthened industry relationships.

Behaviors you’ll need:

• Teamwork and Interpersonal Skills: Strong teamwork capabilities, excellent interpersonal relationships, and communication skills.
• Relationship Building: Proven ability to establish and maintain strong relationships with government officials, industry groups, and other stakeholders.
• Crisis Management: Effective handling of unexpected challenges and crises.

Job requirements:

• Full time employee, 9 working hours including lunchbreak, 5 days of week
• 20% Travel is expected within South Africa and 10% outside the country.
• Office based environment, eligible to work remotely once a week after the probation period