Regulatory Affairs Specialist

Our client is seeking an experienced and knowledgeable Regulatory Affairs Specialist to manage regulatory compliance for their pharmaceutical products within the Free State region. This role is pivotal in ensuring that all product development, manufacturing, and marketing activities align with national and international regulatory standards, including those set by the South African Health Products Regulatory Authority (SAHPRA). You will play a key role in preparing and submitting regulatory dossiers, facilitating approvals, and maintaining compliance throughout the product lifecycle.

This is an excellent remote opportunity to significantly impact market access for vital pharmaceutical innovations.

• Prepare, review, and submit regulatory dossiers for new product registrations, variations, and renewals.
• Liaise with regulatory authorities to ensure timely approval of submissions and respond to queries.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and operations.
• Ensure compliance with all relevant pharmaceutical regulations, guidelines, and company policies.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Maintain regulatory databases and documentation systems, ensuring accuracy and completeness.

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; a Master's degree is advantageous.
• Minimum of 4 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Thorough understanding of South African pharmaceutical regulations and submission processes.
• Experience with dossier preparation using Common Technical Document (CTD) format.
• Strong analytical, problem-solving, and project management skills.
• Excellent written and verbal communication skills, with the ability to negotiate effectively with regulatory bodies.

• Competitive remote salary package.
• Performance-based bonuses.
• Comprehensive medical aid and life insurance.
• Opportunities for professional development and attending industry conferences.
• Flexible working hours to support work-life balance.