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Regulatory Affairs Manager - Established Products (all genders)

Alfred E. Tiefenbacher
Hamburg

Presence / Mobile
Fulltime

Regulatory Affairs Manager - Established Products (all genders), 1. image

Regulatory Affairs Manager - Established Products (all genders), 2. image

Regulatory Affairs Manager - Established Products (all genders), 3. image

As Regulatory Affairs Manager in the Established Products Team you will be the responsible colleague for all regulatory questions related to your established products all around the world with regard to variations and new submissions. You will be the one defining the regulatory strategy how to apply for new marketing authorisations and implement changes in Europe and worldwide for your products.

A challenging task

Maintenance of the marketing authorization approvals including administration and preparation or revision of the chemical-pharmaceutical documentation
Independent planning and execution of national and European registration procedures (MRP, DCP) and variations.
Challenge and work out the most suitable variation strategies for established products based on the current regulatory frameworks
Plan, lead and keep the oversight of complex registration projects
Evaluation and classification from variations under consideration of the European and NON – EU regulatory requirements.
Coordination of the submission of your projects in EU and Non-EU countries and Emerging Countries
Contact person for regulatory issues within the lifecycle projects
Maintaining direct contact with all European regulatory authorities and an international clientel

A convincing background

Successfully completed scientific studies and at least two years of professional experience in the field of regulatory affairs
Ability to work independently and to handle complex tasks, good time management skills
Strong communication skills and solution-oriented way of thinking, ability to deal confidently with people from different backgrounds and cultures
Very good analytical skills, highest standards for the own work and the ability not to lose head or sense of humor even in hectic times
High degree of commitment, sense of responsibility and assertiveness
Very good German and English language skills as well as the confident handling of MS Office complete your profile

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 on site with the freedom 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!