Job Description

Algemene informatie
Job Advert Title
Regulatory Affairs Manager
Locatie
Dubai
Function/Business Area
Regulatory Affairs
Afdeling
Country Cluster Maghreb Algeria
Werkcategorie
Arbeidsovereenkomst voor bepaalde tijd
Functiebeschrijving
Regulatory Affairs Manager - Maghreb
About Astellas :
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
About This Job :
Astellas is currently hiring a Regulatory Affairs Manager - Maghreb, to be based in Algeria. The role will be reporting directly into the Regulatory Affairs Lead, MEA and will be on a one year fixed term contract basis.
Purpose of the Position :
For assigned products and under supervision of Affiliate RA lead/Associate Director RA, timely prepare, submit and conduct appropriate follow-up of new Marketing Authorization and Life Cycle Management applications to the national competent authorities.
For assigned products, provide regulatory guidance to multidisciplinary teams to ensure that development or maintenance activities to be performed in the context of approved business activities are performed in time and in compliance with applicable regulatory demands (legislation and guidelines) throughout the product's life cycle.
For assigned products and tasks, stays updated on relevant and local regulations and guidelines.
Support local implementation of new initiatives, management tools or processes in cooperation with Global and/or Regional RA.
Ensure that processes, procedures and regulatory files are well documented in up to date and complete applicable archives, databases, repositories and trackers.
Develop registration strategies for the assigned projects and develop processes for the improvement of registration timelines.
Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
Acts as substitute for Affiliate RA lead as appropriate
By discretion of Regulatory Affairs Management and due to organization and workload, not all listed activities may need to be performed or additional responsibilities need to be handled.
Essential Knowledge & Experience :
Minimum of 4 to 7 years experience in a similar role having worked across Algeria, Morocco and Tunisia.
Hands on regulatory affairs experience (dealing with most aspects of registration) within the pharmaceutical industry is essential
The incumbent should possess a meticulous attention to details and be flexible enough to successfully handle conflicting time pressures and a large volume of work.
Excellent communication skills and ability to develop and maintain good working relations with internal and external stakeholders. Arabic and English language skills are essential. French, preferred.
Team oriented and collaborative working style
MS Degree in Pharmacy or other Life Science or equivalent by experience
Additional information :
One year fixed term contract
Location - Algeria
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.