Regulatory Affairs Portfolio Manager

About the role

The Regulatory Affairs Portfolio Manager manages a portfolio of pharmaceutical products throughout their regulatory lifecycle, enabling timely patient access, maintaining marketing authorizations and complying with local regulatory requirements and Novartis standards. The role leads the planning, preparation, submission, implementation and tracking of regulatory activities and acts as the strategic regulatory partner to internal and external stakeholders.

Key responsibilities

• Achieve the best possible product registration with commercially attractive labelling in line with the registration plan.
• Maintain and secure product licenses for CMC, clinical data and safety updates in line with local regulations, company strategy and global compliance.
• Ensure compliance with DBE/MCA and other local regulations for related CPO activities such as RIM updates, RMP, packaging materials and promotional materials.
• Foster good relations with internal and external stakeholders and report technical complaints, adverse events and special cases within 24 hours of receipt.
• Develop and execute regulatory plans for new registrations, variations, renewals, safety updates and dossier maintenance.
• Support accelerated approvals, line extensions, new indications and product launches.
• Manage assigned product portfolios across multiple therapeutic areas and align product licenses with global regulatory strategy.

Required profile

• B.Pharm qualification and registration with SAPC.
• 3-5 years of regulatory experience.
• Experience managing complex product portfolios and regulatory work plans, prioritizing submissions, coordinating resources and tracking milestones.
• Ability to lead follow-up on approvals, health authority feedback and implementation actions, and to support business continuity through handovers and portfolio planning.
• Experience partnering with Medical, Quality, Supply Chain, Pharmacovigilance, Commercial, Global Regulatory Affairs, manufacturing sites and external service providers, and building relationships with health authorities.
• English.

Required skills

• Strong knowledge of South African pharmaceutical legislation and SAHPRA processes.
• Project management, attention to detail and dossier quality.
• Knowledge of regulatory information management systems, eCTD processes and regulatory databases.
• Ability to manage multiple submissions and products at once and to provide regulatory guidance across functions.