Regulatory Affairs – Portfolio Lead

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

Our client in the pharmaceutical industry is seeking a Regulatory Affairs Portfolio Lead to manage the preparation, compilation and submission of regulatory dossiers and related documentation for pre-registration and post-registration applications. The role is responsible for supporting the timely registration and ongoing regulatory maintenance of pharmaceutical products in accordance with applicable regulatory requirements.

KEY RESPONSIBILITIES

• Initiate and manage the regulatory registration process for new product submissions.
• Screen, compile and submit registration dossiers to the relevant Regulatory Authorities within required timelines.
• Coordinate the collection of dossiers and supporting regulatory data from suppliers.
• Prepare and submit post-registration updates, variations, resolutions and other required regulatory correspondence.
• Conduct dossier audits, due diligences and post-registration variations in accordance with current regulatory guidelines and applicable regulations.
• Maintain effective relationships with Regulatory Authorities and internal and external stakeholders to support regulatory objectives.
• Manage, audit and support the implementation of regulatory systems.
• Prepare, review and adhere to SOPs and applicable local regulatory guidelines.
• Monitor assigned submissions and follow up with relevant health authorities to support timely product registrations.

MINIMUM REQUIREMENTS

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

The ideal candidate will have a strong detail, quality and compliance orientation, with excellent analytical, problem-solving, time management and communication skills. They should be a self-starter who can work independently, manage multiple projects simultaneously, understand stakeholder needs and consistently meet strict timelines. The role requires adaptability, teamwork, a strong sense of urgency and the ability to perform effectively under pressure. If you are an experienced RA professional ready to manage pharmaceutical product registrations and regulatory lifecycle activities,