Cardinal Health · 16 hours ago
Senior Nonclinical Regulatory Strategist & Submission Author
United States
Full-time
Remote
Senior Level
$123K/yr - $176K/yr
7+ years expCardinal Health is a global leader in healthcare services and products, and they are seeking a Senior Nonclinical Regulatory Strategist & Submission Author. This role is responsible for leading the strategy and authorship of nonclinical components for global regulatory submissions, ensuring compliance and timely delivery while collaborating with cross-functional teams.
Health CareHospitalMedical
Responsibilities
Clinical trial applications and amendments
Authoring nonclinical sections (Modules 1, 2, and 4) of registration dossiers for US, EU, and other regions, including preparing international marketing applications such as IRDs, NDS, BLAs, and JNDAs
Preparing Annual Reports (IND, NDA, Canada YBPR)
Authoring post-approval Supplements, Variations, Renewals, and compliance assessments
Using nonclinical templates and source documentation to prepare nonclinical reports for clinical trial applications, registration dossiers, annual reports, and post-approval submissions
Preparing and updating nonclinical sections of Marketing Applications and Authorizations
Developing global nonclinical regulatory strategies for product development and post-approval lifecycle management
Preparing nonclinical sections for US Annual Reports and DSURs, ensuring accuracy and timely delivery
Preparing responses to Health Authority queries and requests for nonclinical data
Performing inspection-readiness audits of client or vendor facilities
Conducting vendor qualification audits and/or study monitoring on behalf of clients
Maintaining fluency in evolving global nonclinical regulations
Liaising with clients regarding technical submission details and project strategy development
Supporting project management and relationship management activities with clients
Verifying CHRS-prepared nonclinical sections against validated source documentation
Verifying client-prepared nonclinical sections using validated source documentation provided by the client
Conducting dossier conversions of older submissions, involving mapping content to CTD structure, correcting formatting, filling data gaps, and preparing scientific justifications
Verifying formatting, proofreading, transcription accuracy, and OCR outputs prior to dossier finalization
Qualification
Required
Bachelor's degree in a scientific discipline (e.g., chemistry, pharmacy, biology)
Extensive knowledge of global nonclinical regulations and CTD structure (Modules 1, 2, and 4)
Strong understanding of pharmaceutical sciences and drug development processes
Excellent written and verbal communication skills with strong regulatory and technical writing experience
Proven ability to manage multiple projects, competing priorities, and tight timelines
Experience working with global Health Authorities and understanding their nonclinical expectations
Preferred
A minimum of 7 years of nonclinical regulatory experience with demonstrated leadership and project management skills preferred
Advanced degree preferred
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
Company
Cardinal Health
Cardinal Health is a manufacturer and distributor of medical and laboratory products.
10001+ employees
H1B Sponsorship
Cardinal Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (128)
2024 (116)
2023 (140)
2022 (158)
2021 (106)
2020 (142)
Funding
Current Stage
Public CompanyTotal Funding
$1.08B2025-08-28Post Ipo Debt· $1B
2006-08-16Post Ipo Debt· $78M
1983-08-12IPO
Leadership Team
Aaron Alt
Chief Financial Officer
T
Tony Caprio
Executive Vice President
Recent News
Morningstar.com
2026-01-16
Company data provided by crunchbase