Join BioBusiness Summer School to jumpstart your career in Life Sciences by gaining knowledge of business aspects such as product development, IPR, finance and business models. The next edition of the summer school will be organised from 25-29 June 2018 in Amsterdam, Leiden and Utrecht, the Netherlands. Register now!
Life Sciences Regulatory Affairs Consultant
Job Life Sciences Regulatory Affairs Consultant
Regulatory affairs in the pharmaceutical sector is key to ensure product quality and patient safety in order to reach and maintain the Market Authorization agreement. Therefore,
- You will mainly act as a Technical writer for CMC parts of regulatory variations:
- e.g, registration files or variations for EU, US and international,
- e.g, Writing Module 2 of regulatory files derived from completed eCTD Modules 3,
- e.g, Writing IMPDs as far as CMC information is concerned
- You will answer to questions raised by Regulatory Authorities.
- You will be in charge off the updating customer’s tracking system linked to their activities.
- You will be involved in customer’s initiatives for improvement of processes / ways of working.
Altran is the global leader in innovation and high-tech engineering consulting. At Altran Belgium, you get the chance to work on projects among a multisectorial portfolio of more than 300 clients and you become part of our international community of like-minded experts!
Join the 220 employees of the Life Sciences & Chemicals division (ISO Certified) at Altran Belgium and join the team of Chantal, Laëtitia, Marita Géraldine or Dimitri!
Profile Life Sciences Regulatory Affairs Consultant
- Master degree in Life Sciences completed by a Regulatory Affairs degree/interuniversity certificate and/or a relevant experience,
- At least 6 months of relevant experience in technical CMC writing
- Fluent in English and French
- Manages own time to meet agreed short-term targets
- Ensure coherence between contributions / quality of final results
We call ourselves the Innovation Makers. Why? It’s not just because it is one of our corporate values, it’s about our cutting-edge approaches. We strive to innovate & transform the most creative ideas into concrete projects to exceed client expectations.
At Altran we value excellence, care, responsibility, dynamism and innovation.
We’re not just offering you a job; we’re inviting you to be part of our community. We will provide you trainings, tools & grounds to work for top notch companies & engineer the career you like.
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Jumpstart your career
The BioBusiness Summer School is a programme tailored to bridge the gap. By immersing yourself in the business aspects of Life Sciences during this programme, you will learn the basic knowledge of BioBusiness, gain insight in the world of Life Sciences companies, meet leading business leaders and increase your international network.