Director, Global Regulatory Affairs

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Position Summary

For nearly five decades, Cardinal Health Regulatory Sciences’ industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology and medical device companies get their products to market. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns. We provide efficient scientific and regulatory consulting services throughout the full product lifecycle from molecular discovery to FDA approval & full commercialization to product retirement and generic intrusion. Cardinal Health Regulatory Sciences ensures the continued success of obtaining approval in the fastest possible time at the most cost-effective price point creating a foundation for your brand for post-approval success in obtaining the greatest market share possible.

The Director of Global Regulatory Affairs leads a global team of 50 regulatory experts and consultants responsible for regulatory strategy, regulatory submissions, and regulatory agency engagement. This role drives successful regulatory outcomes and plays a key role in developing talent across a distributed team of consultants.

This position reports to the Vice President, Biopharma Regulatory Affairs

Responsibilities

Regulatory Strategy & Leadership

• Develop and execute global regulatory strategies across diverse product portfolios.
• Provide expert leadership to internal teams and clients, ensuring regulatory excellence.

Regulatory Submissions & Compliance

• Direct preparation and management of IND, NDA, and global regulatory submissions.
• Support clinical study design, data analysis, and compliance with FDA, EMA, and ICH requirements.
• Training, Mentorship, & Development of Consultants
• Serve as a hands-on leader committed to developing regulatory consultants at all experience levels.
• Create structured training, onboarding, and professional development programs for consultants.
• Provide routine coaching, mentorship, and skills development aligned with individual growth trajectories.
• Foster a learning culture that emphasizes technical expertise, regulatory judgment, and career mobility.
• Ensure junior and mid-level consultants gain exposure to complex projects and cross-functional teams.

External Agency Engagement

• Build and sustain productive relationships with U.S. and global regulatory authorities.
• Act as spokesperson on significant regulatory matters and strengthen agency dialogue.

Business Leadership & Growth

• Partner with executive leadership to drive business strategy and long-term growth.
• Provide financial oversight including project budgeting and resource allocation.

Qualifications

• 15+ years of pharmaceutical industry experience, including 10+ in regulatory affairs preferred
• Bachelor’s degree preferred; MS, PharmD, or PhD preferred
• Experience in a consulting environment
• Strong business acumen and team leadership skills, developing and growing a consulting team
• Deep technical knowledge of regulatory requirements (FDA, EMA, ICH, GLP, GMP, GCP)
• Strong written, verbal, and cross-functional communication skills
• Proven ability to lead and develop teams, especially consulting or matrixed environments
• Ability to travel up to 25%
• Leadership Attributes:
• Strategic and enterprise-minded leader with a collaborative style.
• Strong mentor committed to developing early-career and established consultants.
• Creative, ethical, and decisive communicator with strong executive presence.

Anticipated salary range

: $ 135,400 – $228,910

Bonus eligible : Yes

Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close

: 3/2/2026 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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If you have questions about this posting, please contact [email protected]