Strategic Regulatory Affairs Portfolio Lead

Boardroom Appointments; Midrand; On-site; ZAR 900,000 - 1,500,000; Full time

Job summary

Boardroom Appointments is recruiting a Regulatory Affairs Portfolio Lead to oversee a portfolio of medicines, ensuring compliance with SAHPRA and the Medicines Act. You will coordinate submissions, manage timelines, and mentor staff in regulatory processes.

The role requires a pharmacy degree and SA Pharmacy Council registration, and at least 3 years in regulatory affairs with experience across development, commercialization and lifecycle maintenance.

Qualifications

• Bachelor's degree in pharmacy or Diploma in Pharmacy.
• Registration with the South African Pharmacy Council.
• 3 years' experience in Regulatory Affairs.
• Experience across product development, commercialization and lifecycle maintenance.
• African territories experience preferred.

Responsibilities

• Manage work streams for the portfolio of products and report on progress.
• Coordinate and submit regulatory dossiers to SAHPRA and other authorities.
• Ensure maintenance and updates of registrations per legislation and guidelines.
• Provide internal training and mentoring on regulatory processes.
• Establish relationships with regulatory authorities and stakeholders.
• Develop regulatory strategies and implementation plans for new products.
• Support regulatory audits and inspections.

Skills

Regulatory knowledge

Project management

Stakeholder management

Quality assurance

Risk management

Education

Bachelor's degree in pharmacy / Diploma in Pharmacy

Job description

Boardroom Appointments is recruiting a Regulatory Affairs Portfolio Lead to oversee a portfolio of medicines, ensuring compliance with SAHPRA and the Medicines Act. You will coordinate submissions, manage timelines, and mentor staff in regulatory processes.

The role requires a pharmacy degree and SA Pharmacy Council registration, and at least 3 years in regulatory affairs with experience across development, commercialization and lifecycle maintenance.