Senior Nonclinical Regulatory Strategist & Submission Author

Senior Nonclinical Regulatory Strategist & Submission Author page is loaded## Senior Nonclinical Regulatory Strategist & Submission Authorlocations:
US-Nationwide-FIELDtime type:
Full time posted on:
Posted Todayjob requisition :
## Role Summary The Senior Nonclinical Regulatory Strategist & Submission Author leads the strategy, planning, and authorship of nonclinical components for global regulatory submissions across development and lifecycle management. This role partners closely with cross-functional technical teams and clients to develop fit-for-purpose nonclinical strategies, author CTD Modules 1/2/4, respond to Health Authority (HA) queries, execute dossier conversions to contemporary standards, and drive inspection/audit readiness—ensuring accuracy, compliance, and on-time delivery.##

Key Responsibilities Responsibilities include, but are not limited to:
* 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.## ## Qualifications
* A minimum of 7 years of nonclinical regulatory experience with demonstrated leadership and project management skills preferred.
* Bachelor’s degree in a scientific discipline (e.g., chemistry, pharmacy, biology); advanced degree preferred.
* 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.

Anticipated salary range: $123,400 - $176,300

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 myFlex Pay
* Flexible spending accounts (FSAs)
* Short- and long-term disability coverage
* Work-Life resources
* Paid parental leave
* Healthy lifestyle programs

Application window anticipated to close: 03/30/2026  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…