Senior Regulatory Affairs Pharmacist — Lead Submissions

AtripleA Recruitment; Johannesburg; Vor Ort; ZAR 900.000 - 1.200.000; Vollzeit

Zusammenfassung

The Senior Regulatory Affairs Pharmacist in Johannesburg will lead regulatory activities to ensure registration, maintenance and lifecycle management of the company''s product portfolio. You will provide technical guidance to the Regulatory Affairs team and coordinate with SAHPRA and other stakeholders.

Responsibilities include dossier submissions (CTD/eCTD), lifecycle management, and regulatory due diligence for new opportunities, while mentoring the team and driving process improvements.

Qualifikationen

• B. Pharm degree and SAPC registration.
• Minimum 5 years' Regulatory Affairs experience in pharma.
• Experience mentoring or leading Regulatory Affairs project teams.
• Solid knowledge of SAHPRA requirements and CTD/eCTD submissions.
• Experience with regulatory document management systems.

Aufgaben

• Regulatory compliance: ensure SAHPRA adherence and guidelines across the portfolio.
• Dossier & lifecycle management: compile, review and submit CTD/eCTD dossiers; manage product changes.
• Business support: review promotional materials and artwork for compliance; support launches.
• Leadership & team development: guide and mentor Regulatory Affairs team; plan workload.
• Operational excellence: monitor submission timelines; identify process improvements and digital tooling.

Kenntnisse

Regulatory affairs

Leadership

Planning

Stakeholder management

Analytical thinking

Ausbildung

B. Pharm degree

Tools

DocuBridge

eCTD

Jobbeschreibung

The Senior Regulatory Affairs Pharmacist in Johannesburg will lead regulatory activities to ensure registration, maintenance and lifecycle management of the company''s product portfolio. You will provide technical guidance to the Regulatory Affairs team and coordinate with SAHPRA and other stakeholders.

Responsibilities include dossier submissions (CTD/eCTD), lifecycle management, and regulatory due diligence for new opportunities, while mentoring the team and driving process improvements.