Senior Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking a meticulous and experienced Senior Regulatory Affairs Specialist to enhance their regulatory compliance efforts in Vereeniging . This vital role involves navigating the complex regulatory landscape to ensure that pharmaceutical products meet all local and international standards for marketing authorization and continued compliance. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and advising internal teams on regulatory strategy.

This is an excellent opportunity for a seasoned regulatory professional to contribute to a growing pharmaceutical company committed to global health standards.

Prepare, review, and submit regulatory submission dossiers (e.g., CTD, NDA, ANDA) for new drug applications and variations. Liaise with regulatory health authorities (e.g., SAHPRA) to respond to queries and facilitate the approval process. Interpret and provide guidance on current and emerging regulatory requirements and guidelines impacting pharmaceutical products. Develop and implement regulatory strategies to support product lifecycle management, including post-approval changes and renewals.

Review promotional materials, labeling, and packaging to ensure compliance with regulatory standards. Conduct regulatory intelligence activities to stay informed about changes in the regulatory environment. Collaborate with cross-functional teams including R&D, Quality Assurance, and Marketing to ensure alignment on regulatory matters.

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. Demonstrated experience in preparing and submitting regulatory dossiers to health authorities. In-depth knowledge of South African pharmaceutical regulations and ICH guidelines. Strong understanding of the drug development process and product lifecycle management. Excellent analytical, written and verbal communication skills, with strong attention to detail.

Competitive salary and comprehensive benefits package. Opportunities for professional growth and development in regulatory affairs. Exposure to a wide range of pharmaceutical products and regulatory challenges. Collaborative work environment focused on compliance and ethical practices. Retirement fund and medical aid benefits.