Senior Regulatory Affairs Pharmacist

About the role

Roche Pharma is looking for a Senior Regulatory Affairs Pharmacist to lead the registration of medicines and new indications in South Africa. You will ensure timely submissions, maintain product dossiers, and support cross‑functional strategies that align with Roche’s global timelines.

Key responsibilities

• Advise on optimal submission timing for new indications and ensure approval by local health authorities.
• Coordinate, monitor and supervise dossier preparation and maintenance in line with corporate SOPs and legislative requirements.
• Gather, analyse and communicate regulatory intelligence to inform business strategies.
• Develop risk‑based registration plans and submission strategies for affiliate products.
• Represent the affiliate in cross‑functional teams and lead special projects.
• Monitor compliance with local pharmacy legislation and internal guidelines, implementing corrective actions when needed.
• Assist product teams with advertising material approvals and collaborate with Quality Assurance on packaging approvals.

Required profile

• Pharmacy degree with extensive experience in regulatory affairs within the pharmaceutical industry.
• Deep knowledge of South African medicine and pharmacy legislation.
• Proven ability to lead complex registration projects and train junior colleagues.
• Strong analytical skills and ability to translate regulatory intelligence into actionable plans.

Required skills

• Regulatory affairs expertise
• Pharmacy legislation compliance
• Dossier preparation and submission
• Regulatory intelligence gathering

What we offer

• Opportunity to work in a global, innovative healthcare company.
• Collaborative environment with cross‑functional teams.
• Professional development and training programs.