Regulatory Affairs Specialist - Pharmaceutical Compliance

Our client, a distinguished pharmaceutical company with a significant market presence, is seeking a diligent and knowledgeable Regulatory Affairs Specialist to enhance their compliance operations in Welkom, Free State . This role is crucial for ensuring that all pharmaceutical products and associated documentation meet the stringent requirements of regulatory bodies such as the South African Health Products Regulatory Authority (SAHPRA) and other international agencies.

You will be responsible for preparing and submitting regulatory dossiers, managing post-approval changes, and maintaining compliance throughout the product lifecycle. This is an exceptional opportunity to build a rewarding career in regulatory affairs within an organisation committed to ethical practices and scientific excellence.

• Prepare, review, and submit regulatory submissions (e.g., new marketing authorizations, variations, renewals) for pharmaceutical products.
• Ensure all submissions are accurate, complete, and compliant with current regulatory guidelines and company standards.
• Maintain and update regulatory databases and filings, ensuring all information is current and accessible.
• Monitor changes in the regulatory landscape and assess their impact on company products and operations.
• Manage post-approval commitments, including advertising and promotion compliance.
• Liaise with regulatory authorities, respond to queries, and facilitate inspections.
• Collaborate with internal departments (e.g., R&D, Quality Assurance, Marketing) to gather necessary information for submissions and ensure alignment.
• Provide regulatory guidance and support to project teams throughout the product development lifecycle.
• Evaluate and manage labeling and artwork changes in accordance with regulatory requirements.

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs, with a strong understanding of South African regulatory requirements (SAHPRA).
• Proven experience in preparing and submitting Common Technical Document (CTD) dossiers.
• Knowledge of global regulatory guidelines and submission strategies.
• Excellent attention to detail and accuracy in reviewing technical and scientific documents.
• Strong analytical and problem-solving skills.
• Effective written and verbal communication skills, with the ability to negotiate and influence.
• Proficiency in regulatory information management systems and standard office software.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Must be legally authorized to work in South Africa and be based in or able to commute to Welkom .

• Competitive salary and potential for performance-based incentives.
• Comprehensive health insurance coverage and retirement savings options.
• Professional development programs and opportunities for career advancement.
• A supportive and collaborative work environment.
• Exposure to diverse product portfolios and regulatory challenges.
• Paid time off and public holidays.