Senior Nonclinical Regulatory Strategist & Submission Author Job
Job Description Job Attributes+
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Job ID
a2b03cac-48da-49c5-8cb6-d8d6941f095f
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Req #
20174328
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Job Location
Remote Location
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Job Category
Research
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Job Type
Regular
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Schedule
Full time
Senior Nonclinical Regulatory Strategist & Submission Author
A professional who combines deep nonclinical science expertise (toxicology, pharmacology, PK/PD) with regulatory strategy and authorship across global markets. They bridge scientific data, regulatory expectations, and development strategy. This is a strategic, cross‑functional, senior scientific regulatory role, not a bench‑focused position.
Responsibilities
Development of regulatory toxicology strategies and study designs for new chemical entities, combination products, devices, biologics, excipients, and impurities.Bridging study design implies experience interpreting legacy data and designing supplemental studies to close gaps.Regulatory meeting request and package preparation with FDA, Health Canada, and EMA.Interaction and negotiations with Health Authorities as required by project (written and verbal).Authoring of nonclinical sections (2.4, 2.6, Module 4) of registration dossiers for US, EU, and other regions, including INDs, CTAs, IMPDs, NDS, BLAs, MAAs, IDEs, and JNDAs and strong scientific writing.Preparation of Investigator Brochure’s, nonclinical protocols, study designs, study reports, and toxicological assessments.Life cycle management –pre- and post- product approval (Annual Reports, DSURs, variations, renewals).Liaising with clients regarding technical submission details and project strategy development.Understanding of GLP, GMP, and GCP and how they apply to preclinical and clinical development.Qualifications
A minimum of 7 years of nonclinical regulatory experience with demonstrated leadership and project management skills preferredBachelor’s degree in a scientific discipline preferred (e.g., Biology, Biochemistry, Pharmacology, Toxicology, Life Sciences, Microbiology); advanced degree preferred such as PhD in toxicology, pharmacology, or related life sciences or Master’s degree (MS, MPH, MBS).Experience in designing, conducting, data analysis, and reporting of nonclinical safety pharmacology, pharmacokinetic, and toxicology studies.Extensive knowledge of global nonclinical regulations and CTD structure.Strong understanding of pharmaceutical sciences and drug development processesExcellent 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 coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication 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 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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