We are growing, grow with us!
Want to work in a dynamic company with daily new challenges and opportunities? Then is PharmaLex your career opportunity.
PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide.
Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.
The success of our company grows with the excellent expertise and the high motivation of our employees.
If for you, your profession is not only a job but a mission too and you enjoy working with people and in teams, then you are highly welcome to join us.
To strengthen our successful team in BELGIUM (Louvain-la-Neuve) we are looking for a:
(Senior) Manager Regulatory Affairs (EU) (f/m/d)
- Extensive knowledge of preparing applications and the handling of centralized procedures in the EU
- Experience in handling orphan drug designations and/or applications and marketing authorizations in Switzerland is highly beneficial
- Planning and implementation of additional approval procedures in the EU (MRP, DCP and purely national procedures) and in emerging markets as well as lifecycle management procedures (e.g. variations, renewals, MAH transfer); worldwide experience is a significant advantage
- Communication and interaction within the project team, with customers, local partners and authorities in an international context
- Revision of approval documents and text management (labeling management) including tracking of updates and implementation
We offer you
- Diverse and challenging job
- Open and appreciative corporate culture
- Flexible working hours based on trust
- Possibility to work part-time
- Possibility to work from home
- Continuous development opportunities through knowledge and experience as well as training
- You have successfully completed a degree in pharmacy, medicine or other life sciences
- You have at least 5 years of professional experience in marketing authorization with a focus on the centralized procedure in the EU, and application procedures in Switzerland . Ideally you also have experience of non-EU countries marketing authorization procedures
- You have sound knowledge of current pharmaceutical and regulatory requirements in the EU, preferably also in Switzerland and non-EU countries
- You have experience in project management, you are capable of multi-tasking, enjoy consulting with customers and have an affinity for databases and project management software
- You are a team player, communicative, conscientious, accurate and responsible
- Flexible and willing to travel
- Confident with MS Excel and MS Word
- Fluent business English skills completes your profile
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.