Compliance

• Leads project teams in implementing and delivering the regulatory strategy across multiple early and/or late-stage programs
• Develop Regulatory Strategy for complex programs in oncology
• Participates in cross-functional teams as regulatory project lead, providing regulatory strategic guidance and support
• Proactively defines and identifies regulatory risk and mitigation plans in support of product development plans
• Drives health authority interactions, including planning, briefing material development, and meeting preparation leadership
• Monitors changes in the regulatory environment, both general and specific to the therapeutic area and supports and advises Development Teams accordingly
• Independently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities
• Partners with external vendors in support of regulatory document preparation and submission
• Leads and executes non-project regulatory activities
• Demonstrates capability and credibility in complex, business critical projects as well as ability to cope with ambiguity and manage key stakeholders.

Senior Director, Global Regulatory Affairs

Senior Principal, IT Governance, Risk and Compliance – GRC

Senior Regulatory Affairs Specialist

Senior Contracts & Compliance Specialist

Compliance Consultant, GDP – Contract

Compliance Intern