Senior Regulatory Affairs Specialist

About the Role

Our client is seeking a seasoned and strategic Senior Regulatory Affairs Specialist to join their remote team, supporting operations from Paarl and across various markets. This crucial role ensures that our client's pharmaceutical products comply with all relevant national and international regulations. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing expert guidance on regulatory strategy.

This position demands a deep understanding of the pharmaceutical regulatory landscape and a proven track record of successful regulatory submissions. You will be a key player in bringing vital medicines to patients by navigating complex regulatory pathways efficiently and effectively.

• Prepare, review, and submit high-quality regulatory dossiers for product registration and variations in various markets.
• Interpret and advise on regulatory requirements and guidelines impacting product development and lifecycle management.
• Serve as the primary point of contact with regulatory agencies, managing communications and responses to inquiries.
• Develop and implement regulatory strategies to support product approvals and post-market compliance.
• Conduct regulatory intelligence activities to stay informed of changes in the regulatory environment.
• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Marketing) to ensure regulatory compliance throughout product development and commercialization.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting various types of regulatory applications (e.g., CTD, MAA, NDA).
• Thorough knowledge of global regulatory requirements and guidelines relevant to pharmaceuticals.
• Excellent analytical, written, and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage multiple projects simultaneously, and meet tight deadlines in a remote setting.

• Competitive salary and comprehensive benefits package, including performance incentives.
• Flexible remote work arrangement, allowing you to work from home in or near Paarl.
• Opportunities for professional development and continuous learning in regulatory affairs.
• Exposure to a diverse range of pharmaceutical products and global markets.
• A collaborative team culture that values expertise and strategic thinking.