Regulatory Affairs & Quality Assurance Manager* (m/w/d)

As a Regulatory Affairs & Quality Assurance Manager, you will play a crucial role in maintaining our local SOP landscape as well as ensuring compliance with regulatory requirements for our pharmaceutical marketing authorizations.

You will be in charge of liaising with regulatory agencies in Germany and Austria and you will coordinate regulatory submissions such as variations or renewal applications.

It is also your responsibility to keep a healthy balance between GMP and business requirements with regard to the SOP system.

At LETI, our focus is on people, both internally and externally, and we welcome employees who bring this guiding principle to life.

• Preparation of variation submissions as part of life cycle management
• Carrying out national and European regulatory procedures
• Participation in the development of approval strategies in close consultation with our Spanish parent company
• Communication and cooperation with authorities
• Coordination of batch releases at the Paul-Ehrlich-Institut
• Support in the maintenance of the local quality system
• Collaboration in the local change control team
• Control of the local SOP landscape
• Management of the internal CAPA system
• Processing of quality-related complaints

Professional skills:

• Completed scientific studies (pharmacy, chemistry, ...) or comparable training
• Relevant professional experience in the field of regulatory affairs
• Good knowledge of quality management
• Very good written and spoken English skills are mandatory
• Knowledge of German is a plus
• Very good MS Office user skills

Personal skills:

• Independent, structured and goal-oriented way of working
• Ability to prioritize different tasks
• Sense of responsibility and reliability

• A responsible, varied job: get actively involved and help shape LETI!
• A collegial environment in which you can develop your full potential
• A good working atmosphere: we treat you with appreciation, respect and focus on people.
• A medium-sized company with flat hierarchies and short decision-making paths
• An attractive salary and social benefits (e.g. company pension scheme, bike leasing, insurance)

You would like to become part of our team?

We look forward to receiving your application, stating your salary expectations and your earliest possible starting date.
Do you have any questions in advance? Please feel free to contact us.