Senior Regulatory Affairs Lead, Drug & Biologic Submissions

Cardinal Health; Charlotte (NC); Vor Ort; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Zusammenfassung

Cardinal Health, Inc. is seeking a Regulatory Affairs and Product Development leader in the United States to provide regulatory submissions and strategy across drug, biologic, and device development from discovery to post-approval maintenance.

The role encompasses authoring and reviewing eCTDs for US and international authorities, overseeing regulatory strategy, and ensuring compliance with approvals such as NDAs and ANDAs, with substantial interaction with Health Authorities.

Qualifikationen

• Excellent verbal and written communication with regulators and teams.
• Experience leading regulatory submissions (eCTD) and strategy development.
• Familiarity with 21 CFR parts and regulatory guidance for sterile injectables.

Aufgaben

• Authorship/review of eCTDs for US and outside-US health authorities.
• Support regulatory strategy for drug development and submissions.
• Ensure compliance with approvals for NDAs, ANDAs, MAAs and DMFs.

Kenntnisse

Communication skills

Negotiation

Teamwork

Independent work

Travel readiness

Regulatory affairs

Ausbildung

Bachelor's degree or equivalent

Advanced degree desirable

Regulatory Affairs Certification

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking a Regulatory Affairs and Product Development leader in the United States to provide regulatory submissions and strategy across drug, biologic, and device development from discovery to post-approval maintenance.

The role encompasses authoring and reviewing eCTDs for US and international authorities, overseeing regulatory strategy, and ensuring compliance with approvals such as NDAs and ANDAs, with substantial interaction with Health Authorities.