Regulatory Affairs Manager

Our client, a well-established pharmaceutical company with operations in Vereeniging , is seeking a strategic and experienced Regulatory Affairs Manager . This role is essential for ensuring that all pharmaceutical products meet the rigorous standards set by regulatory bodies such as the South African Health Products Regulatory Authority (SAHPRA) and other international agencies. You will lead the submission process for new product registrations, manage post-approval changes, and ensure ongoing compliance for a diverse product portfolio.

The ideal candidate possesses a deep understanding of pharmaceutical regulations, strong project management skills, and the ability to navigate complex regulatory landscapes. This is a key leadership position contributing to market access and compliance for essential medicines within Gauteng and beyond.

• Develop and implement regulatory strategies for product registration, lifecycle management, and variations in target markets.
• Prepare, review, and submit regulatory dossiers to SAHPRA and other health authorities in compliance with applicable guidelines.
• Liaise effectively with regulatory agencies, responding to queries and ensuring timely approvals.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Oversee the labeling and promotional material review processes to ensure regulatory compliance.
• Manage and mentor a team of regulatory affairs professionals, fostering their growth and development.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA regulations and submission requirements for pharmaceuticals.
• Proven experience in preparing and submitting successful marketing authorization applications.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Strong leadership and team management capabilities, essential for the Vereeniging
  -based team.

• Highly competitive salary and performance-driven bonus opportunities.
• Comprehensive benefits package including medical aid, disability insurance, and retirement savings.
• Relocation assistance may be considered for candidates outside the immediate area.
• Extensive opportunities for professional development, including attending international regulatory conferences.
• A challenging and rewarding role within a respected pharmaceutical organization focused on quality and compliance.