- Define and oversee global regulatory strategies for the product portfolio, aligned with business priorities and global requirements.
- Drive Galleri commercialization across the EU, Asia/Pacific, the Middle East, and the UK.
- Provide strategy and oversight for regulatory submissions, product approvals, and lifecycle management across geographies.
- Partner with R&D, Quality, Clinical, Commercial, and Manufacturing teams and executive leadership to integrate regulatory considerations into enterprise strategy and portfolio governance.
- Anticipate global regulatory and policy shifts, assess their impact, and shape company responses.
- Prepare the organization for regulatory inspections, audits, and high-level interactions with authorities.
- Influence international regulatory policy through industry forums, standards bodies, and regulatory working groups.
- Lead the development, preparation, review, and execution of international regulatory submissions and product registrations.
- Establish filing strategies, submission plans, timelines, dependencies, and governance for international commercialization.
- Maintain regional registrations, regulatory records, commitments, and submissions, and ensure timely completion of post-approval and post-registration activities.