Vice President, Regulatory Affairs

Responsibilities and Duties

• Lead key regulatory sub-functions composed of experienced team leaders and subject matter experts, ensuring alignment, accountability, and execution at scale.
• Partner with the Head of Global Regulatory Strategy to translate regulatory strategy into execution priorities, operating plans, governance, and measurable outcomes.
• Partner with the Chief Regulatory Officer and Global Regulatory Leads to align resources, capabilities, and execution with regulatory and business priorities.
• Strengthen the systems, processes, and infrastructure needed for faster, scalable, and compliant regulatory execution.
• Drive operational excellence across planning, governance, submission readiness, compliance, and inspection support.
• In partnership with the IT Business Partner, advance the use of artificial intelligence and digital tools to improve productivity, compliance, transparency, and decision-making.
• Oversee execution of global regulatory plans for marketed products, lifecycle management programs, and development-stage assets.
• Support new market entry and global expansion through strong operational readiness.
• Provide leadership across international regulatory execution, CMC regulatory, labeling, and regulatory operations.
• Support regulatory business operations, including annual and quarterly financial planning and budget oversight, workforce and resource planning, and contracting and purchase order activities in support of portfolio and enterprise growth.
• Promote continuous learning and capability building across the regulatory organization.
• Partner cross-functionally to align regulatory execution with enterprise priorities, timelines, and launch objectives.
• Anticipate evolving global regulatory requirements and embed them into processes, submissions, and operating practices.
• Provide senior leadership with execution updates, risk assessments, and pragmatic recommendations.

Qualifications and Skills

• Bachelor’s degree required; advanced degree in a scientific, medical, or related field preferred.
• 15+ years of progressive Regulatory Affairs experience in the biopharmaceutical industry, including deep global regulatory expertise and demonstrated success leading in complex, multi-region environments.
• Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.
• Demonstrated ability to build and strengthen scalable systems, processes, and operating models that improve execution, compliance, visibility, and organizational effectiveness.
• Strong enterprise planning, governance, financial stewardship, and resource allocation capability, with experience leading annual and quarterly planning, budget oversight, workforce planning, and external spend management.
• Demonstrated success leading regulatory execution for commercial-stage products and development programs in the U.S. and international markets, while balancing pace, quality, compliance, and business priorities.
• Strong continuous improvement mindset with pragmatic risk management and problem-solving skills, including the ability to modernize ways of working, navigate ambiguity, and drive measurable progress.
• Strong people leadership, coaching, and talent development capabilities, with a track record of building engaged, accountable, and high-performing teams.
• Ability to thrive in a fast-paced environment while maintaining high standards of quality, compliance, and execution excellence.
• Commitment to patients, ethics, quality, compliance, and company values; rare disease and/or specialty biopharmaceutical experience strongly preferred.