Senior Regulatory Affairs Pharmacist

Lsv Personnel; Johannesburg; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

LSV Personnel in Johannesburg seeks an experienced Regulatory Affairs professional to lead CTD/eCTD submissions and ensure SAHPRA compliance. You will guide internal stakeholders and mentor the Regulatory Affairs team to maintain high-quality submissions.

You will manage product lifecycles, support new launches, and collaborate with Marketing, Supply Chain and Manufacturing to ensure timely, compliant regulatory activities.

Qualifications

• B.Pharm degree and current SAPC registration.
• Minimum 5 years' Regulatory Affairs experience within the pharmaceutical industry.
• Experience mentoring, coaching or leading Regulatory Affairs team members or projects.
• Sound knowledge of SAHPRA requirements, CTD/eCTD submissions and product lifecycle management.
• Proven ability to independently compile and submit regulatory dossiers and manage regulatory authority interactions.
• Experience with DocuBridge/eCTD or equivalent regulatory document management systems.

Responsibilities

• Ensure compliance with SAHPRA legislation and regulatory guidelines.
• Maintain awareness of regulatory changes and communicate their business impact.
• Build relationships with SAHPRA and other regulatory authorities.
• Provide regulatory guidance to internal stakeholders to ensure ongoing compliance.
• Independently compile, review and submit CTD/eCTD dossiers for registrations, variations and other applications.
• Coordinate and prepare responses to SAHPRA queries within agreed timelines.
• Manage lifecycle of assigned products including PI/PIL updates and variations.
• Maintain regulatory records and submission trackers.
• Provide regulatory support for new product launches and lifecycle activities.
• Review and approve promotional materials for regulatory compliance.
• Review artwork, labels and packaging components for regulatory compliance.
• Partner with Marketing, Supply Chain, Manufacturing and New Business Development on regulatory matters.
• Support regulatory due diligence for new business opportunities.

Skills

Regulatory affairs

CTD/eCTD submissions

Mentoring / team leadership

Regulatory submissions management

Cross-functional collaboration

SAHPRA knowledge

Education

B.Pharm degree

SAPC registration

Tools

DocuBridge/eCTD

Job description

Key Responsibilities

• Ensure compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act and applicable regulatory guidelines.

• Maintain awareness of regulatory changes and communicate their business impact.

• Build and maintain effective working relationships with SAHPRA and other regulatory authorities.

• Provide regulatory guidance to internal stakeholders to ensure ongoing compliance.

• Independently compile, review and submit CTD/eCTD dossiers for new registrations, variations, renewals, transfers of ownership and other regulatory applications.

• Compile and review supporting scientific and administrative documentation to ensure high-quality submissions.

• Coordinate and prepare responses to SAHPRA queries and deficiency letters within agreed timelines.

• Manage the lifecycle of assigned products, including PI/PIL updates, labelling changes and implementation of approved variations.

• Maintain accurate regulatory records, document management systems and submission trackers.

• Provide regulatory support for new product launches and lifecycle activities.

• Review and approve promotional and marketing materials to ensure compliance with regulatory requirements and approved product information.

• Review artwork, labels, PI/PILs and packaging components for regulatory compliance.

• Partner with Marketing, Supply Chain, Manufacturing and New Business Development on regulatory matters.

• Support regulatory due diligence for new business opportunities where required.

• Provide day‑to‑day guidance, mentoring and technical support to Regulatory Affairs team members.

• Support workload planning, prioritisation and achievement of departmental objectives.

• Promote collaboration, knowledge sharing and continuous improvement within the team.

• Monitor submission timelines and portfolio priorities.

• Identify opportunities to improve regulatory processes, systems and digital tools.

• Support implementation of automation and process improvements.

Minimum Requirements

• B.Pharm degree and current SAPC registration.

• Minimum 5 years' Regulatory Affairs experience within the pharmaceutical industry.

• Demonstrated experience mentoring, coaching or leading Regulatory Affairs team members or projects.

• Sound knowledge of SAHPRA requirements, CTD/eCTD submissions and product lifecycle management.

• Proven ability to independently compile and submit regulatory dossiers and manage regulatory authority interactions.

• Experience with DocuBridge/eCTD or equivalent regulatory document management systems.