Position Summary
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
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.
To read and review this privacy notice click https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf
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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
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.
To read and review this privacy notice click https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf
#J-18808-Ljbffr