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:
Senior Manager Regulatory Affairs (f/m/d)
- 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
- Strategic input and definition of regulatory strategies regarding definition of intelligent new marketing authorization application strategies, smart approaches such as worksharing procedures and various others
- Coordination and support in preparation of proposals or contractual arrangements with our clients in accordance with the respective client needs and interests; taking charge of regular client contacts to enable a good client relationship
- Communication and interaction within the project team, with customers, local partners and authorities in a regional and/or an international context
- Planning, coordination and moderation of client project kick-off meetings as well as regular client project meetings
- Contribution to and elaboration of current and/or upcoming regulatory topics of strategic impact within the EU and outside, preferably also creation of summaries or evaluations of current regulatory trends to share with our clients etc.
- Potentially take-over of team lead function for a team of 6-10 regulatory affairs colleagues in the department, focusing on people management and development
- Revision of approval documents and labeling management including tracking of updates and implementation
- You speak fluent business English, preferably a second language with at last grade B2 completes your profile
- You have successfully completed a degree in pharmacy, medicine or other life sciences
- You have at least 5 years of professional experience in marketing authorizations with a focus on the EU. Experience in regulatory applications and handling of non-EU marketing authorization procedures is highly advantageous
- You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and a good understanding of local requirements preferably in one ICH region
- You have experience in project management, you are multi-tasking capable, enjoy liaising with different customers and approaching them and have an affinity for databases and project management software
- You bring experience and/or affinity in preparation of proposals or contractual arrangements with our clients and are interested in further expanding these capabilities
- You are a team player, communicative, conscientious, accurate and responsible
- Flexible and willing to travel
- 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.