Regulatory Affairs (Project) Manager (m/f/d)

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

As an International Regulatory Project Manager you will be a member of CDx International Cdx within the International Regulatory Chapter.

In this position you will focus on the support and delivery of high quality regulatory submissions of companion diagnostics to Health Authorities worldwide (except US/EU) for the Roche portfolio.

Your opportunities:

• Products for the respective area of responsibility shall obtain Regulatory approvals in defined markets in close cooperation with other functions.

• The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines.

• The obtained Regulatory approvals/licenses products are maintained throughout the life cycle of the product by managing successful health authority notifications and submission, in accordance with quality management system change control processes.

• Ensure efficiency and success of Regulatory activities and strategies while collaborating closely with other functions, stakeholders and external partners (authorities, companies, NBs etc).

• Provide input to project and product regulatory strategy based on international regulatory requirements and support international regulatory submissions by provision of needed data and documents; answering Health Authority questions on the submissions; keeping our Affiliates informed about new products /projects/ process changes etc.

• The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization.

• The activities are driven by a mindset of innovation, agility and the principles of VACC leadership.

Who your are:

• Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience (Completed training as a technician or laboratory technician; or equivalent qualification for the tasks)

• Profound experience in Regulatory, Clinicaland/or Quality

• Experience in diagnostics or pharmaceutical regulatory affairs is required

• Advanced degree and experience in CDx is considered an advantage.

• Can manage high complexity work and/or global projects, or equivalent experience.

• Proven ability to work autonomously

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a unique opportunity to shape the future of Roche.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Diagnostics International in Rotkreuz is a leading provider of diagnostic systems solutions, and the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland. We are more than 2’700 passionate colleagues from over 65 nationalities. Find out more about our site in Central Switzerland, here.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.