Industrial Pharmacist and Regulatory Manager - Alberton
Air Liquide
How will you CONTRIBUTE and GROW? The Industrial Pharmacist and Regulatory Manager will be responsible for leading and managing the coordination and management of the product registration process for South Africa and all export territories. The selected candidate will oversee the full product lifecycle, including the compilation of dossiers, whilst also providing scientific, medical and technical support. Additionally, the role will assume the responsibilities of a Deputy Responsible Pharmacist and a Local Backup Pharmacovigilance person to ensure the efficient management of the pharmacovigilance (PV) process. Responsible for the activities associated with the approval of a product including such activities as development, coordination, and submission of responses to Regulatory Authority inquiries. Monitor, follow up and report on progress of regulatory submissions and ensure registration, planning, and tracking of regulatory database management. Provide consultative support to product marketing teams on business decisions with regulatory implications. Review promotional material to ensure that it is in compliance with the company's standards and that of the MCC and the Code of Marketing practice. Involved in the negotiation of first approval labeling with regulatory authorities, and labeling revisions over the product's lifecycle. Provide world-class medical information (medinfo) within agreed timelines and release medical products onto the market. ___________________ Are you a MATCH? Requirements Education B.Pharm degree Currently registered with the SA Pharmacy Council Experience At least 3 years experience in Regulatory Affairs At least 2 years in production or quality assurance Knowledge of Dossier compilation & Conversions to eCTD Knowledge of Medical information/pharmacovigilance Knowledge of ISO9001 Our Differences make our Performance At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world. We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.
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