Regulatory Affairs Associate, French West Africa

Ivory Coast, Middle East, Turkey, and Africa

Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world.  We value courage, commitment, trust and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

This position is based in Cote D’Ivoire (Ivory Coast) and will report directly to the Regulatory Affairs Manager, French West Africa (FWA).  The role will be responsible to support the Regulatory Affairs Manager on all regulatory activities within French West Africa (FWA) region, maintain the regulatory archiving and tracking systems up to date as well as manage artwork and product information update.

Your Responsibilities will be  :

• Support the Regulatory Affairs Manager in the assigned Regulatory activities.
• Prepare and compile registration files for submission of initial Marketing Authorization Application (MAAs), variations, renewals and manufacturing site registrations/renewals etc.
• Coordinate the preparation of the submission files in cooperation with the Regulatory Affairs Manager, Global RA and the distributors.
• Review all relevant data and documents from the different departments and/or third parties involved for eligibility (contents) and consistency throughout the regulatory file.
• Collect and compile necessary data, documents and samples (active substance, impurities, finished product) to be included in the regulatory file.
• Prepare responses to requests by the authorities during the evaluation process, and correct handling of deficiency letters within a specific timeframe.
• Support the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
• Monitor new developments in regulatory legislation and guidelines.
• Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the region.

Your Profile :

• Bachelor degree in Pharmacy, Pharmaceutical Sciences, or relevant discipline.
• Minimum of 3 years professional experience in Regulatory Affairs in pharmaceutical industry.
• Experience in the preparation and submission of Regulatory files to the Competent Authorities in FWA.
• Ability to maintain a structure documentation and archiving system as well as work under supervision, multi-task with attention to detail and manage multiple deadlines.
• Self -starter: ability to identify opportunities for improvement with excellent communication skills to work across different cultures.
• Excellent working knowledge of MS Office (Outlook, Word, Excel, PowerPoint)
• Fluent and excellent command of English and French (spoken and written)

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!.

Please note only direct applications via our HR system will be considered.