Regulatory Affairs Pharmacist at Fresenius Group

General Duties: 

• Preparing and submitting medicine registration applications for imported and locally made products in foreign countries.
• Maintaining existing product registrations in foreign countries.
• Responding to any deficiency letters or requests for information from the foreign countries.
• Checking of printed packaging specifications and proofs relevant to these registrations.
• Provision of product registration information on request by the Site Responsible Pharmacist and Export Marketing Managers.
• Assisting the Export Marketing Department with tender information relevant to the company.
• Preparing documents for international company registration in various territories.
• Maintaining the international registration product list.
• Assist with Batch Release when necessary
• From time to time, carry out other jobs within the factory /department, consistent with the grade qualification and training of the incumbent.

Requirements

• B. Pharm / Dip. Pharm.
• Registered Pharmacist with South African Pharmacy Council.
• 2-5 years Industrial Pharmaceutical Regulatory Affairs experience
• GMP, GWP and GDP Principles
• Understand quality investigation requirements (risk assessments, deviations, OOS, change controls)