Compliance

• Develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area.
• Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans.
• Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams.
• Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed.
• Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs).
• Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
• Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments.
• Perform critical review of submission documents to ensure compliance with regulatory requirements.
• Negotiate and manage regional post-approval commitments and global label expansion strategies.
• Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams.
• Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements.
• Support due diligence and business development assessments.
• Identify and resolve regulatory issues that may affect projects or organizational objectives.

Director, Global Regulatory Leader

Senior Regulatory Risk Specialist

Director, Ethics and Compliance Investigations

Director, Global Regulatory Leader

Senior Manager, Quality – Regulatory Affairs