Regulatory Affairs Manager - Established Products (all genders)

Tiefenbacher Group; Hamburg; Híbrido; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

Tiefenbacher Group is seeking an experienced Regulatory Affairs professional to own regulatory lifecycle strategies for established medicines across the EU and beyond. You will develop strategies for changes and new submissions, manage procedures, and liaise with QA, CMC and international partners.

The role emphasizes independent work, strong prioritisation, and clear scientific communication, with a flexible hybrid work model in Hamburg.

Qualificações

• A university degree in a scientific discipline and at least two years in Regulatory Affairs.
• Independent, structured work approach with strong prioritisation skills.
• Excellent analytical abilities and commitment to quality.
• Clear, confident communication and collaboration across cultures.
• Curiosity about regulatory, tech and digital developments; AI interest welcome.

Responsabilidades

• Maintain regulatory authorisations and assess change controls with QA and CMC.
• Plan and manage national and European procedures (MRP, DCP, variations).
• Develop regulatory strategies for changes and new submissions.
• Coordinate regulatory submissions across EU and non-EU markets.
• Lead complex regulatory projects with timelines and priorities.
• Serve as key regulatory contact for products’ lifecycle management.
• Engage with authorities and international partners presenting strategies.

Conhecimentos

Regulatory strategy

Regulatory submissions

Stakeholder management

Project coordination

German & English

Formação académica

Bachelor’s degree in science

Ferramentas

MS Office

Descrição da oferta de emprego

Would you like to combine your scientific expertise with strategic thinking and help shape the regulatory future of established medicines? Join our Established Products team and take ownership of the regulatory lifecycle of your assigned products.

In this role, you will develop regulatory strategies for changes, new submissions and the maintenance of existing marketing authorisations across the EU and international markets. You will explore different approaches, critically assess the available options and turn complex regulatory challenges into scientifically sound, practical solutions.

A challenging task

• Maintain the marketing authorisations for your assigned products and assess change controls from a regulatory perspective, working closely with Quality Assurance, CMC and other relevant functions.
• Independently plan and manage national and European regulatory procedures, including mutual recognition procedures (MRP), decentralised procedures (DCP) and variations.
• Develop and critically evaluate regulatory strategies for changes and new submissions, taking account of current regulatory requirements and legal frameworks.
• Assess and classify changes against the requirements of EU and non-EU markets, and coordinate the associated regulatory submissions.
• Lead complex regulatory projects, keeping timelines, priorities and interdependencies in focus.
• Act as the key contact for regulatory questions concerning your products and their lifecycle management.
• Engage directly with European regulatory authorities and our international customers and partners, presenting your regulatory strategies with scientific rigour, clarity and confidence.
• A university degree in a scientific discipline, such as pharmacy, chemistry, biology or a related field, and at least two years of experience in Regulatory Affairs.
• An independent, structured approach to work, strong prioritisation skills and a genuine interest in solving complex regulatory challenges.
• Strong analytical skills and a commitment to quality, balanced with practical, solution-oriented thinking.
• Clear, confident communication and an enthusiasm for collaborating with people from diverse backgrounds and cultures.
• The resilience and flexibility to adapt to changing priorities while maintaining perspective - and a sense of humour - during busy periods.
• Intellectual curiosity and a willingness to keep learning, staying informed about regulatory, technological and digital developments.
• An interest in artificial intelligence and digital solutions, with the motivation to explore their potential, apply them responsibly and help shape their use in Regulatory Affairs.
• Initiative, accountability and the confidence to advocate for well-founded solutions.
• Excellent German and English language skills and proficiency in MS Office.

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 60/40 hybrid working model, with three days a week in the office and the option to work remotely for the remaining two days.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!