Regulatory Affairs Specialist - South Africa

Placements24; Stellenbosch; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plan

Professional development

Dynamic Stellenbosch work environment

Job summary

Placements24 is seeking a knowledgeable Regulatory Affairs Specialist to join our compliance team in Stellenbosch. The role focuses on ensuring that pharmaceutical products comply with South African regulations for registration, marketing and distribution, liaising with SAHPRA, and managing submission processes.

You will provide regulatory guidance to cross-functional teams, review labeling and promotional materials, and stay abreast of evolving regulatory landscapes to support product

Qualifications

• Bachelor's degree required; experience in regulatory affairs within pharma preferred.
• Experience preparing and submitting regulatory dossiers.
• Strong understanding of SAHPRA requirements and product development.

Responsibilities

• Prepare, submit, and manage regulatory dossiers for SA registrations and variations.
• Liaise with SAHPRA and other regulatory authorities.
• Monitor changes in regulatory guidelines affecting products.
• Provide regulatory guidance to R&D, marketing, and manufacturing teams.
• Review labeling and promotional materials for compliance.

Skills

Regulatory affairs

SAHPRA knowledge

Dossier submissions

Pharma development

Communication

Education

Bachelor's degree in Pharmacy / Life Sciences / Law

Job description

About the Role

Our client is seeking a knowledgeable Regulatory Affairs Specialist to join their compliance team in Stellenbosch . This role is responsible for ensuring that pharmaceutical products comply with all relevant South African regulations for registration, marketing, and distribution. You will liaunt with health authorities, manage submission processes, and stay abreast of evolving regulatory landscapes. This is a critical position that requires sharp attention to detail and a deep understanding of the pharmaceutical regulatory environment, contributing to the company's success in bringing essential medicines to market.

Key Responsibilities

• Prepare, submit, and manage regulatory dossiers for new product registrations and variations in South Africa.
• Liaise with regulatory authorities such as the South African Health Products Regulatory Authority (SAHPRA).
• Monitor and interpret changes in regulatory legislation and guidelines affecting pharmaceutical products.
• Provide regulatory guidance to cross-functional teams, including R&D, marketing, and manufacturing.
• Review promotional materials and product labeling for regulatory compliance.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Law, or a related discipline.
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry, with specific knowledge of SAHPRA requirements.
• Proven experience in preparing and submitting regulatory dossiers.
• Strong understanding of pharmaceutical product development and manufacturing processes.
• Excellent analytical, organizational, and communication skills.

Benefits

• Competitive annual compensation package.
• Comprehensive health insurance and retirement savings plan.
• Support for professional development and attendance at regulatory affairs conferences.
• A dynamic and intellectually stimulating work environment in Stellenbosch .
• Opportunity to shape the regulatory strategy for innovative pharmaceutical products.