Senior Regulatory Affairs Pharmacist – Midrand

About the role

The company is seeking an experienced Senior Regulatory Affairs Pharmacist to lead regulatory activities for its product portfolio in Midrand. You will ensure compliance with South African pharmaceutical legislation and support product development, commercialization, and lifecycle management.

Key responsibilities

• Manage work streams and report on the assigned portfolio of products.
• Conduct dossier due diligence, identifying and closing data gaps.
• Collaborate with internal and external stakeholders to assess regulator submission requirements.
• Maintain up‑to‑date knowledge of relevant Acts, Regulations and Guidelines.
• Establish and nurture relationships with regulatory authorities and other stakeholders.
• Develop and implement regulatory affairs systems, policies and procedures to enhance compliance.

Required profile

• Bachelor’s or Diploma in Pharmacy with registration on the South African Pharmacy Council.
• 3–5 years of regulatory affairs experience, preferably in human medicines.
• Proven experience across product development, commercialization and maintenance lifecycles.
• Strong project management capabilities and a track record of delivering on quality, time and cost targets.

Required skills

• Proficiency with CTD software builders.
• Experience compiling eCTD applications.

What we offer

• Full‑time, onsite position in a dynamic pharmaceutical environment.
• Opportunity to work closely with regulatory authorities and industry experts.