Regulatory Affairs Specialist; Pharmaceuticals

About the Role

Our client is seeking a knowledgeable and proactive Regulatory Affairs Specialist to support their pharmaceutical product registrations and compliance efforts from Pretoria . This role is critical in ensuring that all company products meet the stringent requirements of health authorities, facilitating market access and maintaining compliance across various territories. You will be responsible for preparing and submitting regulatory dossiers, liaising with regulatory agencies, and staying updated on evolving regulatory landscapes.

This is an excellent opportunity to contribute to global health initiatives from the administrative capital of Gauteng .

• Prepare, review, and submit regulatory submissions (e.g., CTD, NDA, ANDA) to health authorities.
• Interpret and advise on regulatory requirements and guidelines relevant to pharmaceutical products.
• Maintain regulatory documentation and ensure compliance with current regulations and standards.
• Serve as a key point of contact with regulatory agencies, responding to queries and requests.
• Track and analyze regulatory changes and assess their impact on the company's product portfolio.
• Collaborate with R&D, manufacturing, and commercial teams to ensure regulatory strategy alignment.

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Master's degree preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Thorough understanding of global regulatory submission processes and requirements (e.g., SAHPRA, FDA, EMA).
• Experience with electronic submission formats and regulatory information management systems.
• Strong analytical and problem‑solving skills with excellent attention to detail.
• Excellent written and verbal communication skills, with the ability to negotiate effectively.

• Highly competitive annual salary.
• Comprehensive health and wellness benefits package.
• Flexible working arrangements, including remote work options.
• Professional development opportunities and support for continuing education.
• A challenging and rewarding role contributing to patient access to medicines in Pretoria .