Regulatory Affairs Portfolio Lead: Dossier Mastery

PSMP; Gauteng; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

PSMP is seeking a Regulatory Affairs Portfolio Lead to oversee the preparation, compilation and submission of regulatory dossiers for pre-registration and post-registration activities. The role supports timely registration and ongoing regulatory maintenance of pharmaceutical products in line with regulatory requirements.

The ideal candidate will lead submissions, coordinate data from suppliers, and maintain strong relationships with authorities and stakeholders while ensuring compliance across

Qualifications

• B.Pharm or Diploma in Pharmacy required.
• Registration with the SAPC.
• 3–5 years’ experience in Regulatory Affairs, preferably in orthodox human medicines.
• Experience across product development, commercialization and maintenance lifecycle.
• Sound project management capabilities.
• Proven ability to deliver to quality, time and cost standards.
• Knowledge of new and emerging Acts, Regulations and Guidelines in pharma.
• Experience using eCTD software.

Responsibilities

• Initiate and manage regulatory registration process for new product submissions.
• Screen, compile and submit dossiers to Regulatory Authorities within required timelines.
• Coordinate collection of dossiers and regulatory data from suppliers.
• Prepare and submit post-registration updates, variations and other regulatory correspondence.
• Conduct dossier audits and post-registration variations per regulations.
• Maintain relationships with Regulatory Authorities and stakeholders.
• Manage, audit and support regulatory systems.
• Prepare, review and adhere to SOPs and local guidelines.
• Monitor submissions and follow up with health authorities to support registrations.

Skills

Regulatory affairs

Dossier submission

Project management

Stakeholder coordination

Education

B.Pharm or Diploma in Pharmacy

Tools

eCTD software

Job description

PSMP is seeking a Regulatory Affairs Portfolio Lead to oversee the preparation, compilation and submission of regulatory dossiers for pre-registration and post-registration activities. The role supports timely registration and ongoing regulatory maintenance of pharmaceutical products in line with regulatory requirements.

The ideal candidate will lead submissions, coordinate data from suppliers, and maintain strong relationships with authorities and stakeholders while ensuring compliance across