Global Regulatory Lead – Pharma (Polokwane)

Placements24; Polokwane; Hybrid; ZAR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Competitive base salary

Medical, dental, and vision insurance

Retirement fund

Paid time off and professional dev

Job summary

Placements24 seeks a Senior Pharmaceutical Regulatory Affairs Manager to lead global regulatory strategies from Polokwane, ensuring timely submissions to SAHPRA, EMA, and FDA. You will manage a team of regulatory professionals and liaise with authorities to maintain lifecycle compliance.

The role requires extensive knowledge of international regulations, strong leadership, and strategic planning to drive innovative medicines to market.

Qualifications

• Advanced degree in Pharmacy, Life Sciences, or related field.
• 10+ years in pharmaceutical regulatory affairs with management experience.
• Proven ability to prepare/submission dossiers (CTD/eCTD).

Responsibilities

• Develop global regulatory strategies for NDAs/MAAs and post-approval changes.
• Lead regulatory submissions to authorities worldwide with accuracy and compliance.
• Mentor and manage a team of regulatory professionals.
• Serve as primary liaison with regulatory agencies and respond to inquiries.
• Monitor evolving regulatory guidelines and advise on impact.
• Review promotional materials and labeling for compliance.
• Collaborate with R&D, clinical ops, manufacturing, and legal to support regulatory goals.
• Oversee pharmacovigilance and lifecycle management.

Skills

Regulatory strategy

Team leadership

Regulatory submissions

Stakeholder communication

Project management

Education

Master's or Ph.D. in Pharmacy/Life Sciences

Tools

CTD/eCTD preparation

Job description

Placements24 seeks a Senior Pharmaceutical Regulatory Affairs Manager to lead global regulatory strategies from Polokwane, ensuring timely submissions to SAHPRA, EMA, and FDA. You will manage a team of regulatory professionals and liaise with authorities to maintain lifecycle compliance.

The role requires extensive knowledge of international regulations, strong leadership, and strategic planning to drive innovative medicines to market.