We are offering a unique opportunity to join our Digital Health Team within Pharma Development Regulatory (PDR). Our highly motivated team is providing regulatory guidance for a portfolio of Digital Health projects, in order to support and drive all of its regulatory aspects. We contribute to Personalized Healthcare (PHC) strategies for Roche Pharma in general and are pivotal at embedding PHC knowledge within PDR.
As a Regulatory Program Manager you support regulatory colleagues in developping and executing regulatory strategies and work on Digital Health initiatives, with a strong focus on digital endpoints/digital biomarkers and software as a medical device (SaMD). For this purpose:
You are a member of Regulatory Affairs Functional Team
You provide regulatory expertise and leadership to site, regional or global cross-functional teams and other groups.
You support teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.
You stay abreast of developments and trends in healthcare, technology / diagnostics and competition relevant to the work of regulatory to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned areas and projects.
You continuously expand your knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs, devices and biologics.
And you apply in-depth knowledge of Roche and regulatory guidelines and procedures
What else are we offering?
We are dedicated to support our staff in development of their knowledge and skills and offer further career opportunities locally and globally where people demonstrate talent and aptitude.
Who are we looking for?
We are seeking a committed individual who brings:
A University degree and at least 1-2 years of relevant experience in regulatory affairs or related functions in Software as Medical Device development
Broad understanding of international regulations, processes and issues in drug/biologics/ digital health, Software as Medical Device development
Practical experience of successfully supporting Health Authority interactions
Strong cross-functional teaming skills: Has consistently excelled in cross-functional teams and regularly demonstrated collaborative and inclusive leadership
Strategic and Creative Thinking: Applies regulatory and scientific knowledge to elaborate solutions and solve complex problems.
Develops clear, effective and creative regulatory strategies to support business needs
Good communication and negotiation skills: Builds trust and respect with peers and team members including external partners and vendors. Influences individuals or groups at more than one level who may have different interests or goals to reach consensus and achieve team objectives.
Ready to apply?
Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs
Hoffmann-La Roche Ltd