Industrial Pharmacist and Regulatory Manager at Air Liquide

Job Summary

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.  

Responsibilities 

• 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 SAHPRA 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