Senior Pharmaceutical Regulatory Affairs Manager

Our client, a respected player in the pharmaceutical landscape, is seeking a highly skilled Senior Pharmaceutical Regulatory Affairs Manager for their operations in Bloemfontein, Free State . This hybrid role allows for strategic planning and collaboration, blending office-based engagement with remote flexibility. You will be responsible for overseeing the regulatory strategy and submission processes for pharmaceutical products, ensuring compliance with national and international regulations.

This includes preparing and filing regulatory dossiers, liaising with health authorities, and providing expert guidance on regulatory requirements throughout the product lifecycle. The successful candidate will be pivotal in navigating the complex regulatory environment, supporting product approvals, and ensuring ongoing compliance. You will contribute to the company's growth and success by facilitating market access for innovative therapies. The role demands a meticulous approach, strong analytical skills, and a comprehensive understanding of pharmaceutical regulations.

Your expertise will be crucial in guiding product development and ensuring adherence to the highest standards of safety and efficacy. This is an opportunity to shape regulatory outcomes and contribute to bringing essential medicines to patients effectively.

• Develop and implement global and regional regulatory strategies for pharmaceutical product development and registration.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities.
• Act as the primary point of contact with regulatory agencies, managing communications and responding to queries.
• Ensure compliance with all applicable pharmaceutical regulations, guidelines, and standards.
• Provide regulatory input and support to R&D, clinical, manufacturing, and marketing teams.
• Assess the regulatory implications of product changes, manufacturing processes, and labeling updates.
• Monitor regulatory intelligence and industry trends, advising the company on potential impacts.
• Lead and participate in regulatory agency inspections and audits.
• Manage post-approval regulatory activities, including lifecycle management and variation submissions.
• Mentor and develop junior regulatory affairs professionals.

• Master's degree or equivalent in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated success in preparing and filing regulatory submissions with major health authorities (e.g., SAHPRA, FDA, EMA).
• In-depth knowledge of ICH guidelines and regional regulatory requirements.
• Strong understanding of pharmaceutical product development, manufacturing, and quality systems.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills, including strong negotiation abilities.
• Proven leadership and project management capabilities.
• Experience with hybrid work arrangements and remote collaboration tools.
• Familiarity with the regulatory landscape in Free State or similar markets is beneficial.

Our client offers a competitive salary and a comprehensive benefits package, including health, retirement, and performance-based incentives. The hybrid work model supports a flexible work-life balance. Employees have access to extensive professional development, including training on new regulations, industry best practices, and leadership skills. This role provides a significant opportunity to influence regulatory strategy and contribute to the successful market introduction of pharmaceutical products in Bloemfontein .

You will join a dedicated and experienced team within a respected pharmaceutical organization, fostering a collaborative and growth-oriented environment. Our client is committed to supporting the career development of its employees and ensuring a positive and productive work experience. The location in Bloemfontein offers a strategic base within South Africa with a good quality of life.