Regulatory Affairs Specialist for Global Markets

Vor 2 Tagen

Rotkreuz, Zug, Schweiz Roche Vollzeit

At Roche, we are pushing the boundaries of healthcare by fostering diversity, equity, and inclusion. Our team is committed to understanding the diverse needs of people worldwide. We believe that every voice matters and contributes to our mission.

The Position

We are seeking a highly motivated individual to join our International Regulatory Affairs team. The ideal candidate will bring an innovative mindset and a proven track record in regulatory affairs. If you are passionate about making a positive impact on global healthcare through regulatory excellence, we invite you to be part of our dedicated team.

  • Obtain regulatory approvals for products in defined markets through collaboration with other functions; compile and coordinate submission documents to support product registration timelines and communicate strategies with health authorities and stakeholders
  • Maintain regulatory approvals throughout the product lifecycle using change controls; ensure regulatory activity efficiency by maintaining agreements with internal functions and external partners
  • Understand, communicate, and implement evolving regulatory requirements and strategies within the organization, and develop innovative regulatory strategies to overcome obstacles and accelerate global approvals
  • Cultivate and utilize relationships with key stakeholders; lead sophisticated initiatives, resolve organizational barriers, and negotiate win-win compromises to influence the current and future direction for Roche and its products
  • Make sound decisions independently and courageously, even outside of comfort zones; embrace decision-making principles and troubleshoot issues, developing proactive and cost-effective solutions to maintain compliance
Key Qualifications

To succeed in this role, you will need:

  • Second-level education and a Bachelor's or Master's degree in Life Science, Data Science, Regulatory Affairs, or a related subject, with advanced degrees considered an advantage. Equivalent experience or qualifications are also acceptable
  • Demonstrated knowledge of Daily Management and Continuous Improvement best practices. Experience ranges from 3-8 years depending on the degree (Ph.D., Master's, Bachelor's) in fields like IVDs, Medical Devices, Pharma, Biopharmaceuticals, with significant experience in Regulatory Affairs
  • In-depth knowledge of global regulatory requirements, guidelines, and procedures, especially for IVD instruments and software. Familiarity with European, US, China, and other international regulations and quality standards is an advantage
  • Strong organizational and communication skills, the ability to multitask, handle multiple projects simultaneously, and work independently in a self-management environment
  • Profound experience in Regulatory Affairs across various functions like R&D, Quality, and Clinical. Some business travel may be required

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