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Regulatory Associate

We are seeking a Regulatory Associate with developing country-based experience to support the regulatory team on the registration of a new maternal health drug worldwide. Our Client is a leading research-based multinational pharmaceutical company.

The main duties will be:
• Liaise with National Regulatory Authorities and agents and distributors in low- and middle-income Countries (LMICs) to collect and evaluate regulatory requirements to support regulatory strategy and timelines for submissions to various Regulatory Authorities
• Support the regulatory team on the preparation of submissions (e.g. registration dossier, variations, scientific advice submissions, translation services).
• Coordinate with the local agents in sub-Saharan Africa, Asia and the middle-east for successful submissions and regulatory approvals
• Provide administrative support to the project, minutes of meetings, arranging teleconferences, timesheet and cost reviews, invoicing etc.
• General regulatory maintenance tasks as required.
Requirements
• University degree (Master’s degree or equivalent degree) in Pharmacy.
• A minimum of 2 years’ experience in international drug regulatory affairs, specifically with drug registrations in Africa and other low and middle-income countries
• In-country experience working with the health sector in LMICs, particularly in African countries.
• In-country experience of working at a regulatory authority
• Ability to work in an international health sector environment preferably involving United Nations/World health Organization
• Good writing skills and speaking/presentation skills
• Written and spoken fluency in English is mandatory – preferred as a first language
• French language is a plus
• High level of proficiency in excel and other Microsoft applications

The candidate must be based in Switzerland and have a valid Swiss work permit. Salary range for the position will be discussed based on experience in the field and other desirable qualifications.

Interested applicants should send a CV to recruitment@conceptfoundation.org. Recruitment is open until 23 April 2020.

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