Regulatory Affairs and Quality Assurance Manager at Roche

Job Description

• We are seeking a Regulatory Affairs and Quality Assurance Manager in Lagos, Nigeria to manage the Regulatory Affairs and Quality Assurance functions for Roche Diagnostics in the West Africa territory (Nigeria and Ghana) and support the export distributors and marketing and sales colleagues.
• The role would involve working closely with the Country Manager, Nigeria with regards to regulatory affairs and quality assurance related projects.
• This role will also serve to assist the Head of Regulatory as the Deputy Local Safety Officer, and coordinator for the West Africa distributor certification and improvement in line with ISO standards.

Responsibilities
The overall objective of this role is to oversee the Regulatory and Quality Affairs for Nigeria and Ghana as directed by management. These include but are not limited to:

• Ensuring the timely preparation of organized and scientifically valid domestic and international product submissions.
• Initiating / completing all product registration activities as assigned within defined timeframe.
• Cultivating and fostering good relationships with all relevant Regulatory organizations (NAFDAC and GHANA-FDA) within assigned territories.
• Submitting weekly plans, monthly activity reports and quarterly reviews to the Head of Regulatory.
• Adhering to corporate principles and exercises policies conforming to Roche values and realize agreed Management Center, Sub regional and Regional Diagnostics programs and objectives.
• Driving high performance culture and cultivates entrepreneurial spirit.
• Taking the lead in ensuring Good Lab Practice by all Roche partners and stakeholders.
• Ensuring timely reporting of all Quality related / Product Complaint issues according to Roche SOP’s.
• Monitoring of dissemination of all Safety Board notices (SBN’s) and Quality Notifications (QN’s).
• Training and monitoring of Roche partners and customers as required on Temperature Monitoring Devices (TMD) use and reporting / downloading.

Requirements
You, as an ideal candidate, will have the following skills, experience and education:

• Medical/ Science degree e.g. Lab Science / Pharma background.
• 4 - 6 years’ work experience in Nigeria; additional experience in Ghana would be an advantage.
• Minimum of 2 years’ experience in Medical Devices / Pharma Regulatory Affairs
• Advanced Computer Literacy in MS Office.