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.