Senior Global Regulatory Affairs Specialist — Remote

Placements24; Rustenburg; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Remote work

Healthcare

Retirement planning

Life insurance

Growth opportunities

Job summary

Placements24 seeks a seasoned Senior Pharmaceutical Regulatory Affairs Specialist to guide regulatory compliance for products manufactured in Rustenburg and distributed internationally, with remote work and significant autonomy.

You will develop regulatory strategies, prepare CTD dossiers, and advise project teams on regulatory implications, ensuring timely submissions and successful interactions with health authorities.

Qualifications

• Bachelors or Masters in Pharmacy, Chemistry, Life Sciences, or related field.
• Minimum 5–7 years of pharmaceutical regulatory affairs experience.
• Experience preparing and submitting registration dossiers (CTD Module 3).
• Familiar with regulatory submission software and databases.

Responsibilities

• Develop and execute regulatory strategies for global product registrations and lifecycle management.
• Prepare, review, and submit CTD dossiers to SAHPRA, FDA, EMA, and other authorities.
• Liaise with agencies, respond to queries, and support inspections.
• Monitor regulatory changes and advise on impact to products and plans.
• Provide regulatory input to development, manufacturing, and commercial teams.
• Ensure promotional materials and labeling comply with guidelines.

Skills

Regulatory strategy

Regulatory submissions

Stakeholder liaison

Regulatory compliance

Education

Pharmacy or Life Sciences degree

Job description

Placements24 seeks a seasoned Senior Pharmaceutical Regulatory Affairs Specialist to guide regulatory compliance for products manufactured in Rustenburg and distributed internationally, with remote work and significant autonomy.

You will develop regulatory strategies, prepare CTD dossiers, and advise project teams on regulatory implications, ensuring timely submissions and successful interactions with health authorities.