A leading pharmaceutical organization renowned for its commitment to compliance, innovation, and excellence is seeking a strategic Regulatory Affairs Manager to join their dynamic team in Johannesburg. This is an exceptional opportunity for senior professionals to lead operational regulatory functions within a culture that values integrity, collaboration, and high ethical standards.

Where You'll Make an Impact:

• Oversee full regulatory compliance in accordance with South African medicines legislation, ensuring adherence to SAHPRA, SAPC, and other regulatory authorities.

• Provide operational leadership across Regulatory Affairs, Quality Assurance, and Pharmacovigilance, driving systems and processes for optimal dossier lifecycle management.

• Cultivate and maintain strong relationships with regulatory stakeholders to support business growth and product approvals.

• Lead and manage cross-functional teams, fostering a compliant, high-performing work environment that prioritizes data integrity and system robustness.

• Make informed, data-driven decisions to navigate complex regulatory landscapes, ensuring timely submissions and ongoing compliance.

Duties:

• Ensure regulatory compliance and governance across all operational activities.

• Manage dossier lifecycle processes, including submissions and renewals.

• Engage proactively with regulatory authorities and internal stakeholders.

• Oversee quality assurance measures and pharmacovigilance oversight.

• Drive operational performance and system integrity.

Requirements:

• Degree in leadership, management, pharmacy.

• Between 3 to 5 years of experience managing regulatory compliance within the pharmaceutical or healthcare industry.

• Proven expertise in dossier submission, lifecycle management, and multi-country regulatory processes.

• Strong leadership and management skills with the ability to influence and engage stakeholders.

• Solid understanding of multi-country regulatory submissions.

• Excellent analytical, organisational, and decision-making capabilities.

• Experience with eCTD submissions and regulatory systems.

• Knowledge of GDP, GMP, and pharmacovigilance practices.