Regulatory Affairs

• Act as an ad interim Regulatory Affairs Manager for the following product categories: medicinal products, medical devices, biocides, detergents & food supplements
• Prepare and file applications for Marketing Authorisations through the national, the mutual recognition or decentralised procedure
• Prepare and file renewals and variations to Marketing Authorisations through the national, the mutual recognition or decentralised procedure
• Provide specialised advice and interpretation of national and European legislation
  
• Regulatory Compliance
  
• CESP submission
• Artwork review

Quality Assurance

• Act as responsible person for distribution activities and/or Qualified Person
• Advice & support on GMP and GDP compliance
• Audit distribution activities
• Write Standard Operating Procedures for Quality Assurance/ System purposes
• Provide advice and assistance in preparation of technical contracts for regulatory compliance purposes
• Apply for authorisations (for distribution of medicinal products, psychotropes,  declarations for export, GMP certificates, ….)
• Audit and setup of ISO 9001:2015 and ISO13485:2016 systems

Information & Publicity

• Act as responsible for information & publicity
• Review of promotional material in line with relevant legislation.
• Control of distribution system of samples
• Request for visa’s (Mdeon, publicity for the general public, radio and TV)
• Provide advice for compliance with code of Ethics
• Write Standard Operating Procedures for Quality Assurance/ System purposes