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 an Associate Program Director - Regulatory you develop and execute regional or global regulatory strategies and initiatives for assigned Digital Health projects, with a strong focus on digital endpoints/digital biomarkers and software as a medical device (SaMD). For this purpose:
You serve as primary PDR representative on one or more regional or global projects
You provide regulatory expertise and leadership to site, regional or global cross-functional teams and other groups. You lead teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment. You manage decision-making surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. You develop regulatory risk management and contingency plans
In alignment with other key partners you communicate the global Digital Health strategy throughout national Roche affiliates
You are the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions
You stay abreast of global 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
As required, you contribute to recruitment activities and on-boarding new staff members
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 3 years of relevant experience in regulatory affairs or related functions in drug and / or 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 dealing with 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.
Fluency in spoken and written English.
Traveling might be required (< 10%)
Roche is an equal opportunity employer.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.