Regulatory Affairs Manager

About Roche

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

The Position

Bring medical innovations safely to their destination and actively shape the future of healthcare. In this role, you will act as the navigator steering our products through the complex sea of global regulatory requirements to sustainably improve the lives of patients worldwide.

Your new team

You will become part of a dynamic Regulatory Affairs team where agility and mutual support are lived every day. We work hand-in-hand with experts from Research, Quality, and Operations to overcome regulatory hurdles together. In our department, we foster a culture of openness where every voice counts and innovation thrives through diversity.

Your new role

• You take on regulatory product responsibility and strategically secure important market approvals in close coordination with internal and external partners
• You coordinate and prepare precise regulatory dossiers for complex products to ensure timely market launches
• Through skillful Regulatory Change Control, you maintain authorizations throughout the entire product lifecycle
• You build resilient relationships with authorities and Notified Bodies, communicating complex matters in a clear and solution-oriented manner
• You drive the use of modern regulatory tools and actively contribute to digital transformation and data stewardship
• With your expertise, you support junior team members and act as a driving force for change within the organization

Who you are

• You hold a completed degree (Bachelor/Master) in Life Science, Data Science, or a comparable field
• You bring at least 5 years (ideally 5–7 years) of professional experience in Regulatory Affairs, Quality, Clinical, or a related area
• You have successfully led complex or global projects and keep a clear head even in turbulent times
• Your way of working is characterized by initiative, entrepreneurial thinking, and the ability to solve problems logically and cost-effectively
• You are a team player who values different perspectives and is able to inspire people toward a common goal
• You communicate confidently in an international environment and are open to occasional business travel

Benefits

Here are our TOP 5 BENEFITS for you at the Mannheim location:

• Langzeitkonto (bei unbefristetem Vertrag): Roche offers you the possibility to transfer part of your salary to a long-term account to use it for financing leave periods during your working life (e.g. for a break, further education, etc.) or for a gradual transition into retirement.
• Vorsorgeplan 2007: With the "Vorsorgeplan 2007", Roche offers additional income in old age besides statutory pension insurance. From the age of 62, you can freely choose when you want to receive your company pension.
• Work-Life-Balance: As a leading healthcare company, we know that a culture that prioritizes work-life balance and health is key to success.
• Language courses, risk coverage, childcare places, childcare subsidy, and internal training opportunities are just some of the many other benefits that await you.
• Attractiveness of the location: Mannheim is the second-largest city in Baden-Württemberg and in the heart of the Rhine-Neckar metropolitan region. Attractive cultural and leisure activities, a variety of international restaurants, numerous cafés, as well as parks and green spaces are waiting to be explored by you!

Further information about us as an employer and your development opportunities can be found on our career page.

Where remuneration transparency is required, we provide information based on the main location of the job. For this position, the main location is Penzberg. If you are interested in another location where the position may also be available, we will provide you with the corresponding remuneration information in the further course of the application process.

Your contact to us! With people. For people.

Do you need further support?

Please have a look at our FAQs, you will find them via https://careers.roche.com/global/en/faq.