Director of Regulatory Strategy

Position Summary As the Director of Regulatory Strategy, you will lead a dynamic team of 50 regulatory professionals and consultants, focusing on developing impactful regulatory strategies, managing vital submissions, and engaging actively with regulatory bodies. This crucial position is key to achieving favorable regulatory outcomes while fostering talent within a geographically diverse team. This role reports directly to the Vice President of Biopharma Regulatory Affairs. Responsibilities Regulatory Strategy & Leadership Formulate and execute comprehensive global regulatory strategies across diverse product portfolios. Provide expert guidance to internal teams and clients, maintaining high standards for regulatory compliance and successful outcomes. Regulatory Submissions & Compliance Oversee the preparation and management of IND, NDA, and various international regulatory submissions. Contribute to clinical study design, data analysis, and compliance with FDA, EMA, and ICH standards. Training, Mentorship, & Development of Consultants Act as an engaged leader committed to the development of regulatory consultants at all experience levels. Create and implement structured training, onboarding, and professional development programs for consultants. Offer ongoing coaching and mentorship aligned with individual career trajectories. Foster a culture of learning that prioritizes technical expertise, regulatory knowledge, and career growth. Ensure that junior and mid-level consultants participate in complex projects and interact with diverse teams. External Agency Engagement Build and sustain effective relationships with regulatory agencies worldwide. Act as a representative on significant regulatory matters and enhance communication with agencies. Business Leadership & Growth Work alongside executive leadership to align business strategies and promote long-term growth. Manage aspects of project finance, including budgeting and resource allocation. Qualifications 15+ years of experience in the pharmaceutical industry, with at least 10 years specializing in regulatory affairs. A Bachelor's degree is required; an MS, PharmD, or PhD is preferred. Previous experience within a consulting environment is an advantage. Strong business acumen combined with proficient team leadership skills. Thorough understanding of regulatory standards (FDA, EMA, ICH, GLP, GMP, GCP). Outstanding communication skills, both written and verbal, as well as ability to collaborate cross-functionally. Demonstrated success in leading and nurturing teams, especially within consulting or matrixed structures. Willingness to travel up to 25% of the time. Leadership Attributes: Strategic thinker who embodies a collaborative leadership style. Dedicated mentor passionate about enhancing the skills of early-career and experienced consultants. Innovative, ethical, and decisive communicator with a strong executive presence. Anticipated salary range: $135,400 - $228,910 Bonus eligible: Yes Benefits: Cardinal Health provides a comprehensive benefits package designed to enhance health and well-being. Comprehensive medical, dental, and vision coverage. Generous paid time off plan. Health savings account (HSA) options available. 401k savings plan option. Access to wages before payday through myFlexPay. Flexible spending accounts (FSAs). Short- and long-term disability coverage. Work-Life resources available for employees. Paid parental leave benefits. Programs promoting healthy lifestyles. Application window anticipated to close: 3/2/2026. If you're interested in this exciting opportunity, please submit your application as soon as possible. The provided salary range is an estimate. Compensation at Cardinal Health is determined based on factors including location, educational background, relevant experience, and skill set, along with internal pay equity assessments. Candidates returning to the workforce, individuals with disabilities, those without a college degree, and veterans are encouraged to apply. Cardinal Health is committed to creating an inclusive workplace that values diverse perspectives. We celebrate our differences and strive to deliver solutions that benefit our customers, ensuring that our employees can express their authentic selves daily.

Created: 2026-03-10