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.
Following a 4–6 month mentorship period, the candidate will assume the role of strategic architect for the CTA process across the EEA and ROW. In this capacity, the CTA Regulatory Expert holds primary responsibility for the strategic oversight of clinical trial regulatory activities. Working in close partnership with Regulatory Programme Managers (EU Partner/GRL), the CTA Regulatory Expert owns the regulatory framework and drives its execution, leveraging cross-functional support to ensure the delivery of global milestones.
The Opportunity
This is a one year Fixed term position, were you will be focusing on:
● Management of Core CTAs or common documents and amendments for EEA and ROW countries: planning, compilation, dispatch, coordination with internal departments and the affiliates, tracking of submissions and approvals in appropriate systems
● Attend key SMT/RAFT meetings (in the planning phase of a clinical trial and further as appropriate) in agreement with the Program Managers
● Interact with various stakeholders for specific CTA related activities
● Support clinical trials in international countries on the need basis in collaboration with the Program Manager
● Work with the senior Clinical Trial Regulatory Affairs Expert or the group manager on various activities like knowledge sharing and maintenance of the information.
● Advise Program Managers on external and internal requirements for CTAs as well as country specific changes based on the experience
Who you are
In Exchange we provide you with:
Salary starts from 2700 EUR gross/monthly. Final salary depends on the successful candidate's level of experience, skills and qualifications.
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.