AC12095 Regulatory Affairs Pharmacist - Waltloo, Pretoria Market-related - South Africa
Alec Cameron & Associates Recruitment Solutions
The main job purpose is to ensure the compliance of pharmaceutical products with regulatory requirements in South Africa and other designated markets. This role involves managing regulatory submissions, writing and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation, and maintaining up-to-date knowledge of regulatory guidelines. Key Responsibilities: 1. Regulatory Submissions: Prepare, compile, and submit regulatory dossiers for new product registrations, renewals, and variations to the South African Health Products Regulatory Authority (SAHPRA) and other relevant authorities. Manage timelines for regulatory submissions and approvals to ensure compliance with project schedules. 2. CMC Writing: Write and review high-quality CMC documentation for regulatory submissions, including Module 3 of the Common Technical Document (CTD). Ensure that CMC documents are accurate, complete, and compliant with local and international regulatory requirements. 3. Regulatory Compliance: Monitor and interpret regulatory requirements and guidelines, including changes to legislation and industry standards. Provide regulatory advice to cross-functional teams to ensure compliance throughout the product lifecycle. 4. Liaison and Communication: Act as the primary contact with regulatory authorities, responding to queries and providing additional information as required. Collaborate with internal departments, including R&D, quality assurance, and manufacturing, to gather necessary information for regulatory submissions. 5. Documentation and Records Management: Maintain regulatory documentation and records, ensuring they are up-to-date and readily accessible. Implement and manage electronic document management systems (EDMS) for regulatory submissions and compliance tracking. 6. Training and Development: Provide training and guidance to junior regulatory affairs staff and other stakeholders on regulatory requirements and best practices. Participate in professional development opportunities to stay current with regulatory trends and updates. Qualifications and Experience: Education: Bachelor's degree in Pharmacy or a related field. Experience: Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry. Demonstrated experience in CMC writing and preparation of regulatory submissions. Experience with SAHPRA submissions and familiarity with South African regulatory requirements. Experience in Docubridge or a similar electronic submission management system will be an advantage. Skills and Competencies: Strong knowledge of pharmaceutical regulations and guidelines (e.g., ICH, SAHPRA). Excellent written and verbal communication skills. Attention to detail and ability to manage multiple projects simultaneously. Proficiency in electronic document management systems (EDMS) and regulatory submission software. Strong organisational and time-management skills. Key Attributes: Analytical and problem-solving abilities. Ability to work both independently and as part of a team. High level of integrity and professionalism. Strong interpersonal skills and the ability to work effectively with diverse teams.
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