Regulatory Program Management Specialist - Program Management

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s 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.
That’s what makes us Roche.
The Pharma Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization. We make decisions quickly and strategically as the environment & landscape evolves. We innovate. Within the PDR Program Management Chapter, we are responsible for delivering global regulatory strategy and end to end execution of clinical projects in the Roche portfolio, in order to develop and maintain Roche product licenses to meet the needs of our patients. We deliver the regulatory components of clinical development and registration programs for products both pre- and post-licensing. We do this by developing innovative and effective global regulatory strategies, assessments and plans and support documentation in collaboration with regional regulatory affairs counterparts, cross functional product teams, corporate partners and global health authorities, based on current regulatory knowledge and expertise.
As a member of this Chapter, you will lead and support global Health Authority interactions and procedures, represent regulatory affairs on cross-functional project teams and ensure the consistent and safe use of our medicines through high-quality labels. Additionally, you understand how data and information contribute to the quality of our submissions.
We are eager to welcome two dynamic and curious individuals to our Regulatory Program Management organization.

Please refer the Job description for details