Regulatory Affairs

Job Description

We are seeking a qualified and experienced Senior Officer/Executive to join our Regulatory Affairs Team. The ideal candidate will specialize in preparing, compiling, and reviewing regulatory dossiers in compliance with international standards and regulatory authority requirements, with a focus on South Africa and other country-specific markets. Roles & Responsibilities: Dossier Preparation and Review: Compile and review high-quality CTD dossiers and variations as per South Africa and other country-specific requirements, including electronic dossier (dB) compilation and publishing. Prepare high-quality eCTD dossiers for new submissions, variations, and responses tailored to regulatory requirements. Agency Communication and Submission: Develop and submit quality responses to agency queries within specified timelines. Collaborate with South African counterparts and principals to validate and electronically publish regulatory documents. Documentation and Compliance: Review and manage scientific and technical documents, including DMFs, CEPs, and drug product-related documents, ensuring adherence to regulatory requirements. Prepare, update, and review product labeling and information. Cross-functional Collaboration: Coordinate with RD&I, manufacturing sites, customers, and principals to gather required documents for dossier compilation. Manage notifications and documentation for implementation of amendments. Regulatory Process Management: Ensure documentation practices align with organizational and regulatory standards. Maintain organized and accurate records for all regulatory activities.Role & responsibilities Requirements: Bachelors or Master’s degree in Pharmacy (B. Pharm or M. Pharm). Proven experience in regulatory affairs, with a specialization in dossier preparation for South Africa or similar markets. Proficiency in electronic publishing tools and CTD/eCTD dossier formats. In-depth understanding of South Africa-specific regulatory guidelines. Strong organizational, communication, and documentation skills. Ability to prioritize multiple projects and meet strict deadlines. Collaborative team player with a proactive and detail-oriented mindset.