Remote Regulatory Affairs Specialist

About the Role

Our client is actively seeking a highly skilled and motivated Remote Regulatory Affairs Specialist to join their global team, supporting operations from Centurion, Gauteng . This position is fully remote, offering the flexibility to work from anywhere within South Africa. You will be responsible for ensuring compliance with national and international pharmaceutical regulations, managing the submission of regulatory dossiers, and maintaining up-to-date knowledge of evolving regulatory landscapes. This role is essential for navigating the complexities of pharmaceutical approvals and market access, contributing directly to the company's strategic goals.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD format) to health authorities like SAHPRA, FDA, and EMA.
• Monitor and interpret regulatory guidelines and advise on their impact on company products and strategies.
• Maintain regulatory documentation, ensuring accuracy, completeness, and adherence to compliance standards.
• Liaise effectively with internal departments (R&D, Manufacturing, Marketing) and external regulatory bodies.
• Manage post-approval changes, variations, and renewals for existing product registrations.
• Conduct regulatory intelligence gathering and report on emerging trends and requirements.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting dossiers for drug registration.
• In-depth knowledge of regulatory requirements in key markets (South Africa, Europe, USA).
• Excellent written and verbal communication skills, with a strong command of English.
• Ability to work autonomously, manage multiple projects, and meet tight deadlines in a remote setting.

Benefits

• Competitive salary and performance-based incentives.
• Generous paid time off and flexible working hours.
• Home office setup stipend.
• Comprehensive health, dental, and vision insurance coverage.
• Opportunities for continuous professional development and international collaboration.