Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is seeking a knowledgeable and proactive Pharmaceutical Regulatory Affairs Specialist to join their expanding team. This role, based in Pretoria , is essential for ensuring that all our client's pharmaceutical products comply with national and international regulatory requirements. You will be responsible for preparing and submitting regulatory dossiers, managing submissions, and liaising with health authorities. This position offers a remote work setup, allowing you to contribute significantly to our client's market access and compliance strategies from the comfort of your home office, supporting their presence in Gauteng and beyond.

• Prepare, review, and submit regulatory dossiers (e.g., CTD format) for new drug applications and variations.
• Monitor changes in the regulatory landscape and assess their impact on our client's products and operations.
• Liaise with regulatory agencies (e.g., SAHPRA) to facilitate the approval process and respond to queries.
• Maintain regulatory compliance for marketed products, including labeling and packaging updates.
• Provide regulatory guidance and support to internal departments, including R&D, manufacturing, and marketing.
• Manage post-approval regulatory activities and ensure ongoing compliance.

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Thorough understanding of regulatory submission processes and guidelines (e.g., SAHPRA, FDA, EMA).
• Experience with dossier preparation and lifecycle management.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work autonomously and manage multiple priorities effectively in a remote environment.

• Competitive salary and annual bonus opportunities.
• Comprehensive health insurance coverage.
• Retirement savings plan with employer contributions.
• Support for professional development and continuing education in regulatory affairs.
• A dynamic and supportive remote work culture that fosters growth and collaboration.