Industrial Pharmacist and Regulatory Manager at 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.

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