Regulatory Affairs Manager

The Position

Roche Global Regulatory Affairs is seeking a professional to support the Sequencing portfolio in the Molecular Customer Area. This role focuses on regulatory projects, systems, software, and hardware-software instrument systems within an open-minded, collaborative environment.

Responsibilities

• Oversee regulatory document and submission compilation, including complex product registration dossiers.
• Develop and manage global regulatory submissions and registration plans, utilizing knowledge of USFDA regulations, including RUO and IVD pathways.
• Interface with external stakeholders, manage relationships, and support audit preparation and execution.
• Lead the organization in adapting to evolving regulatory environments and influence strategies to accelerate worldwide approvals.
• Partner with stakeholders to provide solutions, address problems, and make independent decisions.
• Model leadership, agility, and integrity while fostering an inclusive team environment.

Requirements

• Bachelor’s or Master’s degree in Life Science, Data Science, or a related field; an advanced degree is preferred.
• 3-8 years of experience in IVDs, Medical devices, Pharma, or Biopharmaceutical industries with a focus on Regulatory Affairs.
• Demonstrated knowledge of Daily Management and Continuous Improvement best practices.
• Understanding of European, US, China, and other international regulations.
• Ability to manage complex work and global projects.
• Experience with complex regulatory product launch strategies, including advertisement and promotional reviews for RUO and IVD products, is preferred.