Regulatory Affairs Specialist

About the Role

Our client is seeking an experienced Regulatory Affairs Specialist to join their expanding team in Rustenburg . This role is critical for ensuring that all company products meet the complex and ever-changing regulatory requirements in South Africa and international markets. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing regulatory guidance to cross-functional teams.

The ideal candidate will have a strong understanding of pharmaceutical regulations, excellent attention to detail, and the ability to navigate complex compliance landscapes. This is a key position that directly contributes to the company's market access and product lifecycle management, offering a chance to work in a dynamic and growth-oriented pharmaceutical company.

• Prepare, review, and submit regulatory submissions for new product registrations, variations, and renewals to relevant health authorities.
• Maintain regulatory compliance for all assigned products throughout their lifecycle.
• Interpret regulatory guidelines and assess their impact on company products and processes.
• Serve as a primary point of contact for regulatory agencies, responding to inquiries and addressing regulatory issues.
• Collaborate with R&D, Quality Assurance, and Marketing departments to ensure regulatory requirements are met at all stages.
• Develop and implement regulatory strategies to support product development and commercialization goals.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• A minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting dossiers (e.g., CTD format) for regulatory approvals.
• In-depth knowledge of South African pharmaceutical regulations (SAHPRA) and relevant international guidelines.
• Excellent analytical, organizational, and project management skills.
• Strong interpersonal and communication skills, with the ability to effectively negotiate with regulatory bodies.

• Highly competitive salary package with annual reviews.
• Comprehensive health, disability, and life insurance.
• Pension fund contributions and profit-sharing opportunities.
• Generous annual leave and sick leave benefits.
• Professional development and training programs to enhance regulatory expertise in Rustenburg .