Regulatory Affairs Manager

OttoBauthentic; Johannesburg; On-site; ZAR 1,000,000 - 1,500,000; Full time

Job summary

OttoBauthentic in Johannesburg seeks a strategic Regulatory Affairs Manager to lead regulatory, quality assurance, and pharmacovigilance across operations. You will drive dossier lifecycle management, ensure compliance with SAHPRA, and foster strong relationships with regulatory authorities and internal stakeholders.

The role requires a strong track record in multi-country submissions, data-driven decision making, and team leadership to support product approvals and compliance excellence.

Qualifications

• Degree in leadership, management, or pharmacy.
• 3–5 years regulatory compliance management in pharma/healthcare.
• Expertise in dossier submission and lifecycle management.
• Experience with multi-country regulatory submissions.
• Strong leadership and stakeholder engagement skills.
• Knowledge of GDP, GMP and pharmacovigilance practices.
• Experience with eCTD submissions.

Responsibilities

• Oversee regulatory compliance across operations.
• Manage dossier submissions and renewals.
• Engage with SAHPRA, SAPC and other authorities.
• Oversee QA and pharmacovigilance activities.
• Drive system integrity and performance.

Skills

Regulatory compliance

Dossier submission

Lifecycle management

Multi-country submissions

eCTD submissions

Regulatory systems

Stakeholder engagement

Data-driven decisions

Team leadership

Pharmacovigilance

Education

Pharmacy degree

Leadership/Management qualification

Tools

eCTD systems

Job description

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.