Regulatory Affairs Specialist

Our client is seeking a proactive and experienced Regulatory Affairs Specialist to manage regulatory submissions and compliance for pharmaceutical products within the South African market. This role operates in a fully remote capacity, allowing for significant flexibility. You will be instrumental in navigating the complex regulatory landscape, ensuring that our client's products meet all local requirements and gain timely market approval.

This is a key position for a detail-oriented professional passionate about regulatory compliance and market access in the pharmaceutical industry.

• Prepare, compile, and submit regulatory dossiers for new drug applications (NDAs) and variations to regulatory authorities, primarily SAHPRA.
• Maintain existing product registrations and ensure ongoing compliance with local regulations and guidelines.
• Act as the primary liaison with regulatory agencies, responding to queries and facilitating communication.
• Review and approve promotional materials and labeling to ensure compliance with regulatory standards.
• Monitor changes in the regulatory environment and assess their impact on company products and strategies.
• Support the development and implementation of regulatory strategies for product lifecycle management.

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs, with specific experience in the South African market.
• Thorough understanding of SAHPRA regulations and submission requirements for pharmaceuticals.
• Proven ability to prepare and manage regulatory submission documentation effectively.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently and manage multiple projects efficiently in a remote setting.

• Competitive annual salary commensurate with experience.
• Comprehensive health and wellness benefits package.
• Flexibility of a fully remote working arrangement with potential for occasional travel if required.
• Opportunities for professional development and engagement with industry regulatory bodies.
• Be part of a global team dedicated to bringing essential medicines to patients across South Africa.