Director of Regulatory Affairs Strategy

Position Summary As the Director of Regulatory Affairs Strategy, you will lead a vibrant team of 50 regulatory professionals and consultants. Your focus will be on crafting innovative regulatory strategies, facilitating crucial submissions, and actively engaging with regulatory authorities. This pivotal role is essential for securing favorable regulatory outcomes while nurturing talent within a diverse team. This role reports directly to the Vice President of Biopharma Regulatory Affairs. Responsibilities Regulatory Strategy & Leadership Develop and implement expansive global regulatory strategies across a variety of product portfolios. Deliver expert guidance to internal teams and clients, ensuring compliance and successful regulatory outcomes. Regulatory Submissions & Compliance Oversee the preparation and management of IND, NDA, and other international regulatory submissions. Contribute to clinical study design and data analysis, ensuring compliance with FDA, EMA, and ICH standards. Training, Mentorship, & Development of Consultants Engage as a dedicated leader committed to the growth and development of regulatory consultants at all levels. Design and implement structured training, onboarding, and professional development initiatives for consultants. Provide continuous coaching and mentorship tailored to individual career paths. Cultivate a learning culture focused on technical expertise, regulatory knowledge, and career advancement. Ensure junior and mid-level consultants are involved in complex projects and collaborate with diverse teams. External Agency Engagement Establish and maintain strong relationships with regulatory agencies worldwide. Represent the organization on significant regulatory matters and enhance communication with agencies. Business Leadership & Growth Collaborate with executive leadership to align business strategies and foster long-term growth. Oversee aspects of project finance, including budgeting and resource planning. Qualifications 15+ years of experience in the pharmaceutical industry, with at least 10 years focusing on regulatory affairs. A Bachelor's degree is required; an MS, PharmD, or PhD is preferred. Prior experience within a consulting environment is advantageous. Strong business insight combined with effective team leadership capabilities. In-depth knowledge of regulatory standards (FDA, EMA, ICH, GLP, GMP, GCP). Exceptional communication skills, both written and verbal, and ability to collaborate cross-functionally. Proven success in leading and developing teams, particularly within consulting or matrixed structures. Willingness to travel up to 25% of the time. Leadership Attributes: Strategic thinker with a collaborative leadership approach. Committed mentor passionate about enhancing the skills of both early-career and seasoned consultants. Innovative, ethical, and decisive communicator with a strong executive presence. Anticipated salary range: $135,400 - $228,910 Bonus eligible: Yes Benefits: Cardinal Health offers a comprehensive benefits package focused on your 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 excited about this opportunity, please submit your application promptly. 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 re-entering the workforce, individuals with disabilities, those without a college degree, and veterans are encouraged to apply. Cardinal Health is dedicated to fostering an inclusive workplace that values diverse perspectives. We celebrate our differences and strive to deliver solutions that benefit our customers while ensuring that our employees can express their authentic selves every day.

Created: 2026-03-11