Senior Regulatory Affairs Lead — Strategic Submissions Expert

Cardinal Health, Inc.; Utah; 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

Flex spending accounts (FSAs)

Short- and long-term disability

Zusammenfassung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support submissions for drug, biologics and device development, from discovery through post-approval maintenance.

Responsibilities include drafting and reviewing eCTDs for US and international Health Authorities and shaping regulatory strategy. The role involves ensuring compliance with approvals (NDAs, ANDAs, MAAs, DMFs), leading risk management reviews, guiding manufacturing site regulatory requirements, and

Qualifikationen

• 7+ years of regulatory affairs hands‑on experience in pharma (drug/biologic).
• Bachelor's degree in scientific/regulatory field; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes (face-to-face, teleconference).
• Excellent knowledge of regulatory and cGMP requirements, including 21 CFR parts.
• Experience with European drug applications (NA, MRP, DP, CP) preferred.
• Knowledge of regulatory requirements for radiopharmaceuticals preferred.
• Excellent written and verbal communication, including drafting regulatory documents.
• Proficient with Microsoft Office and tools for managing drug applications.
• Diplomacy and negotiation skills; ability to make decisions.
• Ability to work independently and in teams.
• Occasional travel – 10% or less.
• Regulatory Affairs Certification preferred.

Aufgaben

• Authorship/review/oversight of eCTDs for US and outside-US submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with conditions of approval of NDAs, ANDAs, MAAs and NDSs.
• Oversee risk management reviews and participate in change control processes.
• Provide regulatory guidance for Cardinal Health facilities, CMOs, and labs.
• Manage communication with regulatory agencies and participate in inspections.
• Provide RA input into program/project teams and cross-functional meetings.

Kenntnisse

Regulatory affairs

Project management

Communication skills

Team collaboration

Negotiation

Independent work

Travel readiness

Ausbildung

Bachelor's degree in science/regulatory field

Advanced degree desirable

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support submissions for drug, biologics and device development, from discovery through post-approval maintenance.

Responsibilities include drafting and reviewing eCTDs for US and international Health Authorities and shaping regulatory strategy. The role involves ensuring compliance with approvals (NDAs, ANDAs, MAAs, DMFs), leading risk management reviews, guiding manufacturing site regulatory requirements, and