Regulatory Affairs Pharmacist / Specialist (AA) – (1 year contract)South Africa, JohannesburgReporting Structure: Head of Regulatory Affairs Southern and South AfricaWe have an excellent opportunity available for an experienced Regulatory Affairs Pharmacist / Specialist to join our client, a multinational pharmaceutical company, on a 1-year fixed term basis.We would welcome the opportunity to connect and provide further details if you feel this is the right role for you!Bachelor of Pharmacy Degree/DiplomaRegistered with the SAPC (South African Pharmacy Council)Minimum of 3 – 5 years' experience in Regulatory Affairs in human medicines preferably biologicals (vaccines)Knowledge of regulatory requirements as pertaining to human medicines is mandatoryWorking experience in a manufacturing environment preferably vaccine/sterile is advantageousManagement of change control and working with manufacturing sites to execute regulatory strategiesDemonstrable experience across the product development, commercialization and maintenance lifecycleProven ability to manage complex regulatory issuesProven ability to consistently deliver to time, cost and quality standardsIn-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining to the pharmaceutical industry.Knowledge of FDA, EMA, WHO and local country regulations would be advantageous.Knowledge of the Marketing Code of PracticeStrategic thinkerResponsibilities will include:Support the local, regional and global regulatory organisation in the development, execution and implementation of country-specific regulatory strategies to support the submission and approval of Covid-19 vaccine in South Africa and Southern Africa. This includes new submissions and life cycle management.Develop strong cross-functional partnerships with in-country and above-country colleagues to effectively execute registration strategies for the product.Develop very strong partnerships with the contract manufacturing organisation, project lead, quality operations and GCMC colleagues.Responsible for developing, enhancing and managing relationships with regulatory health authorities (HAs) and Boards of Health (BoHs) including inspectorate and regulatory compliance and pharmaceutical evaluation.Understand local regulations and developing trends in the local regulatory environment.Leverage regulatory knowledge to anticipate barriers and recommend alternative approaches in line with local policies and procedures.Understand WHO process for Emergency Use Listing.Compile and submit new product applications and line extension applications to the relevant HA's/BoHs, ensuring that registration requirements are fulfilled.Responsible for the co-ordination of regulatory activities associated with product approval, including the development and submission of responses to HA queries and requests, and monitoring and following-up on progress of regulatory submissions at the HA.Maintain licenses (e.g., Marketing Authorizations) in compliance with local regulations and ensuring that corporate regulatory processes, SOP's and systems are followed.Maintain compliance in company-specific regulatory systems and databases.Maintain compliance of local product artwork and/or promotional materials in line with local legislation, regulations and company standardsRepresent the regulatory team at cross-functional team meetings and discussions with project team.Where required, represent company at the relevant industry trade association meetings.
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