Regulatory Affairs Manager (all genders) - New Projects
Regulatory Affairs Manager (all genders) - New Projects
Regulatory Affairs Manager (all genders) - New Projects
Regulatory Affairs Manager (all genders) - New Projects
Alfred E. Tiefenbacher
Pharmazeutische Produkte, Arzneimittel
Hamburg
- Art der Beschäftigung: Vollzeit
- 56.500 € – 69.500 € (von XING geschätzt)
- Vor Ort
Regulatory Affairs Manager (all genders) - New Projects
Über diesen Job
Regulatory Affairs Manager (all genders) - New Projects
- Alfred E. Tiefenbacher
- Hamburg
- Presence / Mobile
- Fulltime
As Regulatory Affairs Manager in the New Projects Team you will be the responsible colleague for all regulatory questions related to your new products all around the world. You will be the one defining the regulatory strategy how to apply for new marketing authorisations in Europe and worldwide for your products.
A challenging task
- Responsibility for all Regulatory Affairs issues within the scope of the respective development projects
- Responsibility for the preparation of the submission documentation in conformity with the regulatory guidelines (EU and Non EU)
- Independent planning and handling of national and European approval procedures (MRP, DCP, CP) and variation procedures
- Preparation and supervision of the submission of your projects in non-EU countries
- Responsibility for a non-EU country group regarding regulatory requirements
- Maintaining direct contact with all European regulatory authorities and an international clientele
A convincing background
- Successfully completed scientific studies and ideally 3 years professional experience in the field of Regulatory Affairs
- Used to work independently, have good time management skills, and enjoy complex tasks
- Strong communication skills and solution-oriented mindset
- Mastering business contacts with people from different backgrounds and cultures with confidence
- Very good analytical skills and the highest demands on your work
- Even in hectic times you do not lose neither head nor humor
- Characterized by a high degree of commitment, sense of responsibility and assertiveness
- Good knowledge of German and English as well as the confident use of MS-Office
Our mindset
We strive towards developing curious team members from all over the world who love to challenge the status quo, take on responsibility, enjoy collaborating and have an affinity and passion for health care. At Tiefenbacher, you will meet a fast-paced work environment where everybody is welcome to suggest new ideas and take ownership of their realization. On a daily basis, we are working towards a culture characterized by curiosity, high energy levels and openness to mutual feedback. We also value a good sense of humor and optimism, especially during hectic times.
An exciting environment
You will be working in an internationally successful company in the buzzing heart of Hamburg, directly at the Elbe river. We offer flexible working hours and a hybrid 60/40 working model with 60% office presence and 40% mobile working. This allows you to combine the advantages of personal interaction in the office with the flexibility of mobile working. In addition, you can look forward to a variety of design and training opportunities, language courses, regular team events and a lot of fun besides work. You can expect a varied job in a motivated and friendly team, an uncomplicated interaction with each other and many opportunities to contribute your own ideas. And we have our own canteen with really delicious food. Come and convince yourself!
You are interested in our company and the position we can offer you?
Then we are looking forward to your online-application - Just click on "Apply now!".
- Marie-Theres Blumers
- HR Business Partner