Regulatory Affairs Manager - International CDx
Roche
Summary
As an International 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).
Job description
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.
Who you are
- 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.
Preferred
- Experience in companion diagnostics is a plus.
Requirements
- 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
- Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices
- Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards
- Demonstrated ability to manage more complex work and/or at parts of global projects
- Experience in companion diagnostics is a plus
Benefits
- Discretionary annual bonus
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.