Senior Regulatory Affairs Manager - Submissions & Strategy

Cardinal Health, Inc.; Vermont; Vor Ort; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical coverage

PTO

HSA

401k

MyFlexPay

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Zusammenfassung

Cardinal Health, Inc. in the United States seeks an experienced Regulatory Affairs professional to lead regulatory submissions (eCTD) and development strategy across drug, biologic, and device programs from discovery through post‑approval maintenance.

The ideal candidate has 7+ years of hands‑on RA experience, a strong track record with Health Authorities, and the ability to guide cross‑functional teams. Occasional travel (about 10%) is expected; advanced regulatory certifications are preferred.

Qualifikationen

• 7+ years of regulatory affairs hands‑on experience in the pharmaceutical industry
• Bachelor's degree or equivalent in scientific or regulatory field preferred; advanced degree desirable
• Documented interface with Health Authorities via multiple modes
• Excellent knowledge of regulatory and cGMP requirements (21 CFR parts etc.)

Aufgaben

• Authorship/review/oversight of eCTDs for US and outside-US health authorities
• Support regulatory strategy for drug development
• Ensure compliance with NDA/IND/MAA/DMF approvals
• Oversee risk management reviews and change control processes
• Provide regulatory guidance for manufacturing sites, CMOs, and contract labs
• Manage communication with regulatory agencies and participate in inspections
• Provide RA input into program/project teams and cross-functional meetings

Kenntnisse

RA leadership

eCTD filings

Regulatory strategy

Cross-functional

Regulatory guidance

Ausbildung

Bachelor's degree in life sciences

Regulatory certification preferred

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. in the United States seeks an experienced Regulatory Affairs professional to lead regulatory submissions (eCTD) and development strategy across drug, biologic, and device programs from discovery through post‑approval maintenance.

The ideal candidate has 7+ years of hands‑on RA experience, a strong track record with Health Authorities, and the ability to guide cross‑functional teams. Occasional travel (about 10%) is expected; advanced regulatory certifications are preferred.