Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is seeking a proactive and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their team, ideally based in or near Port Elizabeth , with the flexibility of remote work. This role is essential for ensuring that all company products comply with national and international regulatory standards, facilitating timely product approvals and market access. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes.

This position offers the chance to contribute to global health by navigating complex regulatory pathways and ensuring the successful launch of innovative pharmaceutical products.

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA) to health authorities such as SAHPRA.
• Ensure compliance with all applicable regulatory requirements and guidelines throughout the product lifecycle.
• Communicate effectively with regulatory agencies, responding to queries and addressing concerns.
• Monitor changes in the regulatory environment and assess their impact on company products and strategies.
• Collaborate with R&D, manufacturing, and marketing teams to provide regulatory guidance and support.
• Maintain regulatory documentation and databases, ensuring accuracy and completeness.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 4 years of experience in pharmaceutical Regulatory Affairs .
• Strong understanding of regulatory submission processes and guidelines in key markets.
• Experience with electronic submission formats and regulatory information management systems.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently in a remote setting and manage multiple projects effectively.

• Competitive annual salary with performance-based incentives.
• Remote work flexibility, allowing for a comfortable and efficient work environment.
• Comprehensive medical, dental, and retirement benefits.
• Opportunities for professional development and growth in a dynamic field.
• A supportive team that values collaboration and expertise in regulatory compliance.