Senior Regulatory Affairs Specialist

About the Role

Our client, a dynamic pharmaceutical manufacturer, is seeking an experienced Senior Regulatory Affairs Specialist to enhance their team in Welkom, Free State . This role is critical for ensuring that all products comply with national and international regulatory standards. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing strategic regulatory guidance to cross-functional teams. The ideal candidate will possess a strong understanding of pharmaceutical regulations and a proactive approach to regulatory challenges. This is an exceptional opportunity to contribute to the success of a growing company and to play a key role in bringing safe and effective medicines to market from a remote capacity.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD format) for new product registrations and variations in accordance with SAHPRA and other relevant authorities.
• Liaise directly with regulatory agencies, responding to queries and addressing deficiencies in a timely manner.
• Monitor and interpret changes in regulatory legislation and guidance, assessing their impact on the company's products and operations.
• Develop and implement regulatory strategies to support product development and lifecycle management.
• Review promotional materials, labeling, and packaging to ensure regulatory compliance.
• Provide regulatory guidance and support to R&D, marketing, and manufacturing departments.
• Maintain regulatory databases and ensure accurate record-keeping.
• Manage post-approval regulatory activities, including annual renewals and change controls.
• Ensure all regulatory submissions and activities related to products available in Welkom and beyond meet the highest standards.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
• Master's degree or equivalent experience is a plus.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• Thorough knowledge of South African pharmaceutical regulations (SAHPRA) and international guidelines (e.g., ICH).
• Proven experience in preparing and submitting registration dossiers for various product types.
• Strong analytical skills and the ability to interpret complex regulatory information.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage multiple projects, and meet tight deadlines in a remote setting.
• Proficiency in regulatory information management (RIM) systems and MS Office Suite.
• Demonstrated ability to navigate the regulatory landscape effectively for products intended for markets including Welkom .

Benefits

• Competitive annual salary package of ZAR .
• Performance-based incentives.
• Home office stipend and IT support for remote work.
• Comprehensive health insurance and retirement savings plan.
• Opportunities for continued professional development and training.
• Flexible working hours and the ability to work from home, supporting the Welkom region.