Core Lab Network Lead: Global Regulatory Strategy

Roche Holding AG; Indianapolis (IN); On-site; USD 200,000 - 371,000; Full time

Job summary

Roche Holding AG in Indianapolis seeks a Core Lab Network Lead to translate customer and business needs into regulatory priorities and guide squads across Regulatory Affairs.

You will drive best-in-class development and submission strategies, foster an agile mindset, and ensure timely access to data and dossiers for global registrations while mentoring Squads and collaborating with Chapter Leaders.

Qualifications

• Bachelor or Advanced degree in science or related field.
• 10+ years of experience in Regulatory Affairs within diagnostics or related field.
• Experience with global submissions for US FDA, EU Notified Bodies, and International.
• Strong strategic thinking and communication skills.
• Experience leading cross-functional teams in a matrixed organization.

Responsibilities

• Translate customer and business strategy into regulatory priorities for the Core Lab Network.
• Drive regulatory strategies and deliverables to support global registrations.
• Collaborate with Core Lab Customer Area, LCTs, and other Networks to align priorities.
• Serve as translator of strategy to Regulatory Affairs, managing Squads and timelines.
• Provide guidance and mentorship per Servant-Leadership and VACC principles.

Skills

Regulatory Affairs

Leadership

Cross-functional Collaboration

Strategic Thinking

Job description

Roche Holding AG in Indianapolis seeks a Core Lab Network Lead to translate customer and business needs into regulatory priorities and guide squads across Regulatory Affairs.

You will drive best-in-class development and submission strategies, foster an agile mindset, and ensure timely access to data and dossiers for global registrations while mentoring Squads and collaborating with Chapter Leaders.