Job Description

RA Portfolio Lead - Prescription Division Regulatory
Gauteng - South Africa
Our client in the pharmaceutical industry is seeking an experienced and detail-driven Regulatory Affairs Portfolio Lead to manage product registrations, lifecycle activities and regulatory compliance across a diverse prescription medicines portfolio. The successful candidate will drive dossier submissions, ensure adherence to legislative requirements, and support strategic business objectives through effective regulatory planning and execution.
Key Responsibilities

• Manage the assigned regulatory portfolio, ensuring efficient execution of all registration and lifecycle activities.
• Coordinate and participate in meetings related to the product portfolio, providing regulatory updates to stakeholders.
• Initiate and manage new product submissions and pre-registration activities, including screening, compiling and submitting dossiers to regulatory authorities.
• Maintain and update product registrations in line with legislation, guidelines and regulatory timelines.
• Prepare and submit variations, resolutions, updates and correspondence for South Africa and SSA markets.
• Ensure the regulatory document database is accurately maintained and all dossiers remain current.
• Conduct dossier audits, due-diligence reviews and post-registration variations to support business objectives.
• Build and maintain effective relationships with regulatory authorities and internal/external stakeholders.
• Monitor regulatory changes and communicate impacts to the business.
• Support SOP adherence and contribute to regulatory guideline updates.
• Provide oversight, guidance and development to junior regulatory team members where required.

Minimum Requirements

• Bachelors degree in Pharmacy.
• 35 years experience in Regulatory Affairs within human medicines (biological/biosimilar experience advantageous).
• Experience across product development, commercialisation and lifecycle management.
• Knowledge of relevant Acts, regulations and guidelines affecting the pharmaceutical industry.
• Experience using CTD/eCTD software, and familiarity with SAHPRA electronic platforms.
• Strong administrative accuracy and documentation management capability.

The ideal candidate will have strong communication skills, excellent attention to detail, and a high level of regulatory and compliance awareness. A proactive mindset, strong project management ability, and the capacity to collaborate effectively with internal and external stakeholders are essential for success in this role. If this is you please apply on the link provided below.
Apply for this Job

Skills Required