Senior Regulatory Affairs Pharmacist
3 weeks ago
Emporium Human Capital is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. The ideal candidate will have experience in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices.
Key Responsibilities:
Manage work streams for- and report on the assigned portfolio of products: internal product queries from relevant departments, external product queries from the SAHPRA, other MRAs, and third-party stakeholders. Establish regulatory priorities and allocate resources and workloads. Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards. Coordinate and submit new product applications in South Africa and other applicable territories. Develop regulatory strategies and implementation plans for the preparation and submission of new products, focusing on complementary medicines and medical devices. Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicines. Prepare registration applications for submission to the regulatory authorities. Work in collaboration with internal and external stakeholders to assess regulators' submissions requirements. Ensure maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations, and guidelines for variations (CMC & Labelling), Renewals, Artwork updates, etc. Update and maintain databases, trackers, and systems for all regulatory related activities. Quality Management System: comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained. Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry. Internal training and mentoring of peers when required. Establish and maintain effective relationships with Regulatory Authorities, internal, and external stakeholders. Formulate or implement regulatory affairs systems, policies, and procedures to ensure that regulatory compliance is maintained or enhanced. Support activities such as internal audits or regulatory agency inspections. Ensure alignment of personal and company values. Core competencies include experience in use of CTD software builder and compilation of eCTD dossier applications. IT skills including Microsoft Office. Ability to prioritize and work to tight deadlines. Systems and operations analysis. Basic cost management skills. Active learning. Strategic thinking. Ability to cope with a high degree of complexity and change. Cross-Functional skills: ability to network, liaise, and negotiate with others. Ability to set standards and objectives and monitor progress. Complex problem-solving and decision-making skills. Customer relationships. Development of people. Must demonstrate responsibility, excellence, and collaboration and align with Company values.
Requirements:
Bachelor's Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council.
+-5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.
Demonstrable experience across the product development, commercialization, and maintenance lifecycle. Sound project management capabilities. Proven ability to consistently deliver to quality, time, and cost standards. Good Manufacturing Practices (GMP). Pharmaceutical production experience or exposure to supplement regulatory knowledge.
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