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Regulatory Affairs Manager (all genders) – Labelling & Own Brands

Alfred E. Tiefenbacher
Hamburg

Presence / Mobile
Fulltime

Regulatory Affairs Manager (all genders) – Labelling & Own Brands, 1. image

Regulatory Affairs Manager (all genders) – Labelling & Own Brands, 2. image

Regulatory Affairs Manager (all genders) – Labelling & Own Brands, 3. image

As Regulatory Affairs Manager in the "Labelling & Own Brands" team, you will be responsible for all regulatory tasks relating to our marketed products in the relevant European focus markets. You will be part of a team that coordinates the regulatory strategy for the implementation of variations or new submissions. This includes processing product information texts as well as taking full responsibility for the change control process and coordinating artwork activities.

A challenging task

Independent coordination of change control processes for marketed products
Preparation and submission of variations
Review and update of product information texts (SmPC, PiL, labelling) in the context of marketing authorisation applications and variations
Timely implementation of safety-related text changes and coordination of internal implementation
Maintenance of marketing authorisation
Collaboration in the planning and implementation of national and European marketing authorisation procedures (MRP, DCP)
Contact person for regulatory issues
Direct contact person for European regulatory authorities and an international group of partners

A convincing background

Successfully completed scientific degree or comparable training in the pharmaceutical/natural sciences field
Ideally, initial professional experience in the field of regulatory affairs
Independent working style, good time management
Strong communication skills and solution-oriented mindset
Enjoy working with people from different backgrounds and cultures
Ability to keep a cool head and sense of humour even in hectic times
High level of commitment and sense of responsibility
Very good knowledge of German and English as well as 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!