Employer Active
Job Alert
You will be updated with latest job alerts via emailJob Alert
You will be updated with latest job alerts via emailAt 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. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.
The Regulatory Value Partner reporting to the Regulatory Drug Safety Medical Information and Quality Excellence Lead is a role within the Medical Value Center with significant responsibilities and critical importance ensuring the effective management of regulatory activities across the product lifecycle from early development through postmarketing activities. In this role you can provide scientific value and make an impact on the patient outcomes. Regulatory Value Partner networks and collaborates with internal (local/global) and external partners of the healthcare ecosystem to foster scientific and regulatory excellence for the benefit of patients.
The Opportunity
Manage regulatory activities for assigned products across their lifecycle ensuring compliance with local and global regulations.
Review and approve promotional materials ensuring alignment with local regulations and company policies.
Collaborate with local Health Authorities and internal teams on preapproval access programs to ensure access to therapies for patients with serious or lifethreatening conditions.
Build and maintain strategic partnerships with local Health Authorities to drive regulatory alignment and ongoing compliance.
Oversee regulatory quality systems ensuring regulatory documentation is uptodate and inspectionready.
Act as backup for managing the product artwork process ensuring compliance and accuracy.
Foster positive relationships with crossfunctional teams both locally and globally to ensure smooth regulatory operations and alignment.
Monitor local regulatory trends and updates providing insights and guidance to internal teams as needed.
Who You Are
Healthcare or life science background with 35 years of experience in Regulatory Affairs.
Strong critical thinking and understanding of the pharmaceutical business and healthcare environment.
Selfmotivated with excellent prioritization skills and a sense of urgency.
Effective networking teamwork and collaboration within a complex matrix organization.
Outstanding communication in both Greek and English with excellent digital competencies and a growth mindset.
A healthier future drives us to innovate. Together more than 100000 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 lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Full-Time