Regulatory Affairs Specialist — SA Pharma Growth

Placements24; LegKraal Gate; On-site; ZAR 480,000 - 720,000; Full time

Benefits offered by this job

Medical aid

Pension fund

Paid time off

Professional development

Job summary

Placements24 is seeking a Regulatory Affairs Specialist in Mahikeng, North West, to ensure regulatory compliance for drug registrations. You will prepare, review, and submit CTD dossiers, liaise with SAHPRA, and guide internal teams on regulatory expectations.

With 3–5 years of pharmaceutical regulatory experience and strong attention to detail, you will monitor changes, manage submissions, and support inspections while collaborating across R&D, manufacturing, and marketing.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• A Master's degree is advantageous.
• 3–5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SA regulations and submission requirements.
• Familiarity with ICH guidelines is a plus.
• Proven experience in preparing and submitting regulatory dossiers.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and meet deadlines.
• Proficiency in regulatory information management systems and standard office software.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD) for registrations and post-approval changes.
• Liaise with regulatory agencies (e.g., SAHPRA) to facilitate reviews.
• Ensure submissions comply with guidelines and policies.
• Manage lifecycle of approvals, including renewals and amendments.
• Provide regulatory guidance to R&D, manufacturing, and marketing.
• Monitor regulatory changes and assess impact on products and processes.
• Maintain regulatory databases and document management systems.
• Contribute to regulatory strategies for new product development.
• Support regulatory inspections and audits.
• Review labeling and promotional materials for compliance.

Skills

Regulatory submissions

Attention to detail

Written and verbal communication

Project management

Time management

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related life science

Master's degree advantageous

Tools

Regulatory information management systems

Office software proficiency

Job description

Placements24 is seeking a Regulatory Affairs Specialist in Mahikeng, North West, to ensure regulatory compliance for drug registrations. You will prepare, review, and submit CTD dossiers, liaise with SAHPRA, and guide internal teams on regulatory expectations.

With 3–5 years of pharmaceutical regulatory experience and strong attention to detail, you will monitor changes, manage submissions, and support inspections while collaborating across R&D, manufacturing, and marketing.