Vacancy: Regulatory Affairs ManagerJan 11, 2022
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Are you ready to pioneer together with us? We are looking for a Regulatory Affairs Manager to boost our team.
At AxTalis, we are at a pivotal point in our transformation towards a fully integrated and cross functional Market Access, Medical Affairs and Regulatory Affairs agency with international footprint. AxTalis is a consulting company with the ambition to become a leading company in the field of strategic Market Access, Medical Affairs operational support and Regulatory lifecycle management.
Are you ready to pioneer together with us? We are looking for a Regulatory Affairs Manager.
Working at AxTalis:
You will be part of a very dynamic and innovative group of driven professionals. Like our clients, our team is dedicated and result driven. We are focused on long term relationships in changing market dynamics. We all have an open ‘growth’ mindset, stimulating each other to keep evolving both personally and professionally.
About the Job
As Regulatory Affairs Manager you will work closely with our team to contribute to the development and implementation of Regulatory, Pharmacovigilance, QA and Compliance activities for our clients in Belgium, the Netherlands, and the Nordic countries. Also, you will be involved in the Market Access and Medical Affairs teams as required by the projects. Consequently, this is a broad position which requires flexibility and a growth mindset. It is an opportunity to develop and/or use a variety of skills and deep knowledge of the 3 Pharmaceutical Affairs pillars in pharmaceutical industry.
Strong networker with ability to influence internal and external stakeholders.
Dynamic and ambitious professional.
Strategic & innovative thinker, but not afraid to get his/her hands dirty.
Team player - accountable and entrepreneurial.
Able to manage multiple tasks in a complex environment.
Excellent stress and time management and ability to handle priorities and deadlines.
Passionate about creating and communicating the value story of healthcare solutions.
About your knowledge & skills:
Master/PhD degree in science (Biomedical sciences, Biotechnology, Pharmaceutical sciences, Drug Development, Medical Doctor, Biosciences), or equal through experience gained in Pharmaceutical Industry.
Languages: Dutch/French/English (by preference native French or Dutch).
About your experience:
Previous experience in a pharmaceutical company or an agency providing consulting/clinical services to pharmaceutical industry is a benefit.
Having the technical regulatory knowledge of local/EMA regulatory requirements is considered beneficial.
First experience with local / EU GVP requirements is valuable.