Senior Regulatory Affairs Lead - Global Submissions & Strategy

Placements24; Centurion; Hybrid; ZAR 900,000 - 1,200,000; Full time

Job summary

Placements24 in Centurion, Gauteng seeks a Senior Regulatory Affairs Specialist to oversee compliance of pharmaceutical products with SAHPRA and international standards, manage registrations, variations and post-approval changes, and shape regulatory strategy across markets. The role requires a Bachelor’s in Pharmacy/Science/Law, 5–7 years in regulatory affairs, CTD knowledge, and strong communication.

You will collaborate with development, manufacturing and marketing teams to ensure timely

Qualifications

• Bachelor's degree in Pharmacy, Science or Law required.
• 5–7 years in regulatory affairs within pharma.
• Knowledge of SAHPRA regulations and CTD format required.
• Experience in preparing and submitting regulatory applications.

Responsibilities

• Prepare and manage regulatory dossiers for NDAs, variations and renewals per SAHPRA requirements.
• Provide regulatory guidance to product development, manufacturing and marketing teams.
• Monitor regulatory changes and assess impact on products and operations.
• Liaise with regulatory agencies and external partners on submissions and inquiries.
• Review labeling, packaging and promotional materials for compliance.
• Develop and implement regulatory policies and procedures.
• Conduct regulatory due diligence for BD activities and acquisitions.
• Maintain regulatory databases and documentation.
• Lead or participate in regulatory inspections and audits.

Skills

Regulatory affairs

SAHPRA knowledge

CTD format

Stakeholder management

Education

Bachelor's degree in Pharmacy/Science/Law

Master's degree or certification

Tools

Regulatory information systems

Job description

Placements24 in Centurion, Gauteng seeks a Senior Regulatory Affairs Specialist to oversee compliance of pharmaceutical products with SAHPRA and international standards, manage registrations, variations and post-approval changes, and shape regulatory strategy across markets. The role requires a Bachelor’s in Pharmacy/Science/Law, 5–7 years in regulatory affairs, CTD knowledge, and strong communication.

You will collaborate with development, manufacturing and marketing teams to ensure timely