Regulatory Affairs Project Manager / Regulatory Affairs Manager

Roche

13d

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. 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. As an International Regulatory Project Manager / Regulatory Affairs Manager you will be a member of the CDx International Regulatory subchapter. 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 (ex-US/EU). The Opportunity You will secure regulatory approvals for products within your area of responsibility by collaborating closely with cross-functional teams across defined markets. You will coordinate and compile submission deliverables in a timely manner to ensure all product registrations stay on track with planned timelines. You will maintain product licenses throughout their entire life cycle, managing successful Health Authority notifications and submissions in strict accordance with quality management change control processes. You will drive the efficiency and success of regulatory strategies by fostering strong partnerships with internal stakeholders and external entities, including Health Authorities and Notified Bodies. You will provide strategic regulatory input based on international requirements and directly support global submissions by managing data, addressing Health Authority inquiries, and keeping international affiliates informed of key project updates. You will serve as a subject matter expert, ensuring that complex regulatory requirements and strategic goals are clearly communicated, implemented, and kept transparent across the organization.

Requirements

• Regulatory Affairs Project Manager: You hold a Bachelor’s or Master’s degree in Life Science, Data Science, or a related field (or possess equivalent professional experience).
• You bring at least 5 years of experience within Regulatory, R&D, Quality, Operations, and/or Clinical environments.
• You are capable of managing high-complexity work and leading global projects.
• You have a proven ability to work autonomously and drive results with minimal supervision.
• Regulatory Affairs Manager: You have a Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
• You have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
• You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
• You have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards.
• You have demonstrated the ability to manage more complex work and/or at parts of global projects.

Nice To Haves

• You possess experience in diagnostics (highly preferred) or pharmaceutical regulatory affairs.
• Experience in companion diagnostics and International markets (APAC preferred) is a plus.
• Experience in companion diagnostics is a plus.

Responsibilities

• Secure regulatory approvals for products within your area of responsibility by collaborating closely with cross-functional teams across defined markets.
• Coordinate and compile submission deliverables in a timely manner to ensure all product registrations stay on track with planned timelines.
• Maintain product licenses throughout their entire life cycle, managing successful Health Authority notifications and submissions in strict accordance with quality management change control processes.
• Drive the efficiency and success of regulatory strategies by fostering strong partnerships with internal stakeholders and external entities, including Health Authorities and Notified Bodies.
• Provide strategic regulatory input based on international requirements and directly support global submissions by managing data, addressing Health Authority inquiries, and keeping international affiliates informed of key project updates.
• Serve as a subject matter expert, ensuring that complex regulatory requirements and strategic goals are clearly communicated, implemented, and kept transparent across the organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level