We are growing, grow with us!
Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is 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 also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us.
To strengthen our successful team, we are looking for a:
Manager Regulatory Affairs (f/m/d)
- Preparation of clinical trial applications to both, Health Authorities and Ethic Committees in Germany incl. handling of submission of substantial amendments and their classification as well as end of trial notifications
- Preparation of applications and handling of marketing authorizations in the DACH region (Germany, Austria, Switzerland) including handling of local requirements
- Planning and implementation of approval procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as of lifecycle management procedures (e.g. variations, renewals, MAH transfer) worldwide
- Communication and interaction within the project team, with customers, local partners and authorities in a regional and/or an international context
- Revision of approval documents and labeling management including tracking of updates and implementation
- You speak fluent business German or German is your mother tongue, English language skills should be at least grade B2
- You have successfully completed preferably a degree in pharmacy, medicine or other life sciences or a bachelor’s degree in science, engineering or mathematical domain
- You have at least 2 -3 years of professional experience in clinical trial applications in Germany and/or DACH region.
- You bring experience in handling of marketing authorizations and their lifecyle management with a focus on the EU. Experience in regulatory applications and handling of non-EU marketing authorization procedures is appreciated
- You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and preferably in one ICH region
- You have an affinity for databases and project management software and are used to closely monitor and adhere to timelines
- You are a team player, communicative, conscientious, accurate and responsible
- Confident with MS Excel and MS Word
We offer you
- Diverse and challenging job
- Open and appreciative corporate culture
- Flexible working hours based on trust
- Possibility to work reduced number of hours
- Possibility to work from home
- Continuous development opportunities through knowledge and experience as well as training
If you are interested in taking over this most challenging job opportunity in our future-oriented company and want to develop as well as our company, we look forward to receiving your application documents stating your earliest possible starting date and salary expectations online.
For further information please don’t hesitate to contact us:
Senior Specialist Human Resources
Agencies only by prior agreement for the specific job opportunity.