Regulatory Affairs Project Manager

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 IVDs (including companion diagnostics) to Health Authorities worldwide.

Opportunity

• 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.

Who you 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).
• At least 5 years experience, 5-7 Years preferred, in regulatory, R&D, quality, operations and/or clinical.
• Experience in diagnostics (highly preferred) preferred or pharmaceutical regulatory affairs.
• 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.

Target Grade

SE6 to SE7

Ready to take the next step?

We’d love to hear from you. Apply now to explore this exciting opportunity!

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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
- changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.