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

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!