Senior Regulatory Affairs Pharmacist

Human Accent; Gauteng; On-site; ZAR 1,000,000 - 1,500,000; Full time

Job summary

Human Accent is seeking a Senior Regulatory Affairs Pharmacist to join our client’s Parktown-based team. You will oversee regulatory activities for registration, maintenance and lifecycle management of the product portfolio, providing technical guidance to the Regulatory Affairs team and liaising with SAHPRA and other stakeholders.

Responsibilities include managing CTD/eCTD submissions, coordinating labeling updates, ensuring compliance with the Medicines Act, mentoring staff, and driving

Qualifications

• B.Pharm degree with current SAHPRA registration.
• Minimum 5 years' Regulatory Affairs experience in pharma.
• 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 compile and submit regulatory dossiers and manage authority interactions.

Responsibilities

• Ensure compliance with SAHPRA legislation and applicable regulatory guidelines.
• Independently compile, review and submit CTD/eCTD dossiers for registrations, variations, renewals and transfers.
• Coordinate and prepare responses to SAHPRA queries and deficiency letters.
• Maintain regulatory records, submission trackers and labeling updates across products.
• Provide regulatory support for new product launches and lifecycle activities.

Skills

Regulatory knowledge

Leadership potential

Planning & organisation

Communication

Analytical thinking

Attention to detail

Education

B.Pharm degree

Tools

DocuBridge/eCTD

Job description

Our well-established client in the pharmaceutical industry has a vacancy available for a Senior Regulatory Affairs Pharmacist to be based at the Parktown office.

The Senior Regulatory Affairs Pharmacist is responsible for managing and coordinating regulatory activities to ensure the successful registration, maintenance and lifecycle management of the company's product portfolio. The role provides technical guidance to the Regulatory Affairs team, supports business objectives through sound regulatory decision-making, maintains effective relationships with SAHPRA and other stakeholders, and contributes to the continuous improvement of regulatory systems and processes.

Key Responsibilities

Regulatory Compliance

• 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.

Dossier & Lifecycle Management

• 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.

Business Support

• 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.

Leadership & Team Development

• 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.

Operational Excellence

• 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.

Behavioural Competencies

• Strong technical regulatory knowledge
• Leadership potential and ability to mentor others
• Excellent planning and organisational skills
• Strong communication and stakeholder management
• Analytical thinking and sound judgement
• Accountability and attention to detail
• Collaborative approach and continuous improvement mindset

Decision-Making Authority

• Recommend regulatory approaches for submissions and lifecycle activities.
• Prioritise workload within agreed departmental objectives.
• Escalate regulatory risks and compliance issues where appropriate.
• Represent the department during routine interactions with SAHPRA and external partners.
• Utilise existing proven relationships with SAHPRA to support regulatory submissions, communications, and compliance activities.