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.

As a Medical Assessment Senior specialist PMS within Post Market Quality you are part of RSS Regulatory Pharma.

The Opportunity:

As a key member of our team, you'll be instrumental in ensuring our products are aligned with all regulatory requirements. This is a highly collaborative role where you'll have the chance to apply your expertise and help drive projects forward.

Coordinate and prepare regulatory submission packages for both new and existing products.

Compile all required materials for submissions, license renewals, and annual registrations.

Recommend strategic changes to labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.

Monitor and improve tracking and control systems for regulatory documentation.

Stay updated on regulatory procedures and changes, and potentially interact directly with regulatory agencies.

Support the screening and evaluation of scientific literature and competitor recalls for post-market surveillance (PMS) reports.

Act as a resource for less experienced colleagues and provide functional guidance.

You're a proactive and detail-oriented professional with a strong background in the regulatory field. You thrive in an independent role where you can apply your expertise to solve complex challenges.

You have a Medical Doctor (MD) degree with min. 2 years of relevant experience.

You possess a strong understanding of regulatory procedures and are diligent about staying up-to-date with changes.

You're a great communicator who can coordinate effectively across multiple teams and departments.

You have strong IT skills, particularly with Google Suite and AI applications.

You are fluent in English and have a strong sense of quality, a confident manner, and a solution-oriented mindset.

Willingness to travel (5-10% annually)

In exchange we provide you with:

Development opportunities: Roche is rich in learning resources. We provide constant development opportunities, free language courses & training, the possibility of international assignments, internal position changes and the chance to shape your own career. 

Excellent benefits & flexibility:  competitive salary and cafeteria package, annual bonus, Private Medical Services, Employee Assistance Program, All You Can Move Sportpass, coaching / mentoring opportunity, buddy program, team buildings, holiday party. We also ensure flexibility, to help you find your balance: home office is a common practice (2 office days/week on average, and we provide fully remote working conditions within Hungary).  We create the opportunity for freedom in working, where your corporate and private life coexist in harmony.

A global inclusive community, where we learn from each other. At Roche, we cooperate, debate, make decisions, celebrate successes and have fun as a team. That’s what makes us Roche.

Please read the Data Privacy Notice for further information about how we handle your personal data related to the recruitment process: https://go.roche.com/dpn4candidates 

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.