Regulatory Affairs – Portfolio Lead

About the role

Our client in the pharmaceutical industry is looking for a Regulatory Affairs Portfolio Lead to oversee the preparation, compilation and submission of regulatory dossiers for both pre‑registration and post‑registration activities. The role ensures timely product registration and ongoing regulatory maintenance in line with local requirements.

Key responsibilities

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

Required profile

• B.Pharm or Diploma in Pharmacy, registered with the SAPC.
• 3–5 years of experience in Regulatory Affairs, preferably within orthodox human medicines.
• Demonstrated experience across product development, commercialization and maintenance lifecycle.
• Strong project management capabilities and ability to deliver to quality, time and cost standards.
• Knowledge of new and emerging Acts, Regulations and Guidelines relevant to the pharmaceutical industry.

Required skills

• Experience using eCTD software for dossier preparation and submission.
• Project management skills to handle multiple regulatory projects simultaneously.