Regulatory Affairs Portfolio Manager

Major accountabilities:

• Achieve the best product registration with commercially attractive labelling in accordance with registration plan
• Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance –
• Ensure compliance with DBE/MCA, relevant local regulations and laws for related CPO activities (RIM updates, RMP, product packaging material, promotional materials/activities, g etc.)
• Foster and maintain good relations with internal and external stakeholders –
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.

Key performance indicators

• Manage assigned product portfolios across multiple therapeutic areas.
• Develop and execute regulatory plans for new registrations, variations, renewals, safety updates, and dossier maintenance activities.
• Support accelerated approvals, line extensions, new indications, and product launches.
• Maintain current product licenses and ensure alignment with global regulatory strategy.

Minimum Requirements

Work Experience:

• Manage complex product portfolios and regulatory work plans.
• Prioritize submissions, coordinate resources, and track milestones.
• Lead follow-up activities for approvals, health authority feedback, and implementation actions.
• Support business continuity through handovers, portfolio planning, and workload management.
• Partner with Medical, Quality, Supply Chain, Pharmacovigilance, Commercial, Global Regulatory Affairs, manufacturing sites, and external service providers (Cross Cultural Experience).
• Build and maintain effective relationships with health authorities and industry stakeholders.
• Provide regulatory guidance and influence cross-functional decision making.

Skills

• Strong regulatory knowledge of South African pharmaceutical legislation and SAHPRA processes.
• Effective project management and prioritization skills.
• Attention to detail and dossier quality.
• Strong stakeholder management and communication capabilities.
• Ability to manage multiple submissions and products simultaneously.
• Regulatory systems knowledge (e.g., Regulatory Information Management systems, eCTD processes, regulatory databases).
• Cross-functional collaboration and compliance mindset.

Languages:

• English.

Education & Qualification

• B.Pharm. Registration with SAPC.

• Regulatory Experience: 3-5 years.