Senior Regulatory Affairs Pharmacist

Job Description

• A leading pharmaceutical organisation is seeking an experienced Senior Regulatory Affairs Pharmacist to join their Regulatory Affairs team. The successful candidate will be responsible for managing regulatory activities, ensuring compliance with applicable legislation, supporting product registrations, and overseeing lifecycle management activities across the product portfolio.
• This role requires strong technical regulatory knowledge, excellent attention to detail, and the ability to manage regulatory submissions while collaborating with internal and external stakeholders.

Key Responsibilities

• Ensure compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act, and relevant regulatory guidelines.
• Monitor regulatory changes and communicate potential business impacts.
• Maintain effective relationships with regulatory authorities and key stakeholders.
• Compile, review, and submit CTD/eCTD dossiers for:
• New product registrations
• Variations
• Renewals
• Transfers of ownership
• Other regulatory submissions
• Prepare responses to regulatory authority queries and deficiency letters.
• Manage product lifecycle activities, including:
• PI/PIL updates
• Labelling changes
• Packaging updates
• Approved variations
• Maintain accurate regulatory records, submission trackers, and document management systems.
• Provide regulatory support for product launches and lifecycle projects.
• Review promotional materials, artwork, labels, packaging components, and product information for compliance.
• Collaborate with internal teams, including Marketing, Supply Chain, Manufacturing, and New Business Development.
• Provide technical guidance, mentoring, and support to Regulatory Affairs team members.
• Assist with improving regulatory processes, systems, and operational efficiencies.

Requirements

• B.Pharm degree.
• Current registration with the South African Pharmacy Council SAPC.
• Minimum 5 years' Regulatory Affairs experience within the pharmaceutical industry.
• Minimum 2 years' experience specifically within Regulatory Affairs Pharmacist responsibilities.
• Strong knowledge of:
• SAHPRA requirements
• CTD/eCTD submissions
• Product registration processes
• Product lifecycle management
• Proven experience independently compiling and submitting regulatory dossiers.
• Experience managing regulatory authority interactions.
• Experience with DocuBridge/eCTD or similar regulatory document management systems.
• Previous mentoring, coaching, or leadership experience within Regulatory Affairs would be advantageous.