Regulatory Affairs Manager - Established Products (all genders)

Regulatory Affairs Manager - Established Products (all genders)

Join to apply for the Regulatory Affairs Manager - Established Products (all genders) role at Tiefenbacher Group

Regulatory Affairs Manager - Established Products (all genders)

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Join to apply for the Regulatory Affairs Manager - Established Products (all genders) role at Tiefenbacher Group

As Regulatory Affairs Manager in the Lifecycle 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
• 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

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 you flexible working hours and the opportunity to work on a mobile basis. 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!

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Purchasing, Product Management, and Project Management

• Industries

  Pharmaceutical Manufacturing

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