About Cardinal Health

Cardinal Health, a Fortune 500 healthcare services and products leader, empowers pharmacies, hospitals, and healthcare providers nationwide. With annual revenue exceeding $200 billion, we specialize in pharmaceutical distribution, medical product manufacturing, and regulatory consulting through our Cardinal Health Regulatory Sciences (CHRS) division. Our mission: to advance healthcare by optimizing supply chains, ensuring regulatory compliance, and accelerating drug development. Join a company committed to innovation, integrity, and inclusion, where diverse teams drive solutions that save lives and improve patient outcomes.

Role Overview

The Senior Nonclinical Regulatory Strategist & Submission Author at Cardinal Health is a pivotal leadership role in our CHRS team. Reporting to regulatory leadership, you'll spearhead nonclinical strategies for global submissions across drug development and lifecycle management. This remote, US-nationwide position offers flexibility while demanding expertise in CTD authoring, Health Authority interactions, and compliance excellence. With a salary range up to $176,300 plus bonus, this role suits seasoned professionals ready to influence global pharmaceutical regulations.

What You'll Do Daily

Collaborate with cross-functional teams to craft fit-for-purpose nonclinical strategies. Author critical CTD Modules 1, 2, and 4 for INDs, NDAs, BLAs, and international dossiers like IRDs and JNDAs. Respond to HA queries with precision, ensuring on-time delivery amid tight timelines.

Key Responsibilities

As a strategic leader, your impact spans the full regulatory lifecycle:

• Lead clinical trial applications, amendments, and global marketing authorizations.
• Author nonclinical sections for US, EU, and other regions, including post-approval supplements, variations, and renewals.
• Prepare IND/NDA Annual Reports, DSURs, and Canada YBPRs using validated templates.
• Develop comprehensive nonclinical strategies for product development and lifecycle management.
• Execute dossier conversions, mapping legacy content to CTD standards with scientific justifications.
• Conduct inspection-readiness audits, vendor qualifications, and study monitoring.
• Liaise with clients on submission strategies, verify documentation accuracy, and maintain regulatory fluency.

Qualifications & Requirements

To excel, bring:

• Minimum 7 years of nonclinical regulatory experience, with proven leadership and project management.
• Bachelor’s degree in chemistry, pharmacy, biology, or related science; advanced degree preferred.
• Deep expertise in global nonclinical regulations, CTD structure (Modules 1/2/4), and pharmaceutical sciences.
• Exceptional regulatory writing, communication, and multitasking under pressure.
• Hands-on experience with Health Authorities, audits, and international submissions.

Candidates without college degrees, back-to-work professionals, people with disabilities, and Veterans are encouraged to apply. Cardinal Health values diverse experiences.

Benefits & Perks

Cardinal Health invests in your well-being with industry-leading benefits:

• Comprehensive medical, dental, and vision coverage.
• 401k savings plan with generous company match.
• Paid time off, parental leave, and work-life resources.
• Health savings account (HSA), flexible spending accounts (FSAs), short/long-term disability.
• myFlexPay for early wage access and healthy lifestyle programs.
• Bonus-eligible role with competitive salary based on experience and location.

Career Growth

Advance your regulatory career at Cardinal Health. This senior role offers pathways to Director-level positions, global project leadership, and cross-functional influence. Access mentorship, training in evolving regulations (e.g., ICH updates), and exposure to cutting-edge pharma projects. Our inclusive culture fosters professional development, with 80% of leadership roles filled internally.

Professional Development Opportunities

Participate in regulatory conferences, HA workshops, and internal academies. Build expertise in emerging areas like biologics, gene therapies, and digital submissions.

Why Join Us

Cardinal Health stands out in regulatory services with our scale, client-centric approach, and commitment to compliance. Work remotely nationwide while partnering with top pharma clients. Enjoy a collaborative environment celebrating diversity—our differences fuel innovation. With application window open until March 30, 2026, secure your future in a stable, growth-oriented company. Salary determined by location, skills, and equity; anticipated $123,400-$176,300.

Role FAQs

Is this role remote?

Yes, US-Nationwide-FIELD allows flexible remote work across the United States.

What salary can I expect?

Anticipated $123,400-$176,300 USD/year, bonus-eligible, based on qualifications and location.

Do I need prior CTD authoring experience?

Yes, extensive knowledge of Modules 1/2/4 and global submissions is essential.

What benefits stand out?

Full medical suite, 401k match, PTO, parental leave, and myFlexPay for financial flexibility.

How does Cardinal Health support diversity?

We encourage applications from underrepresented groups, Veterans, and non-traditional candidates, fostering an inclusive workplace.

Apply now to shape the future of global regulatory strategy at Cardinal Health. (Word count: 1,248)