Remote Regulatory Affairs Manager

Cardinal Health, Inc.; Lansing (MI); Remote; 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)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Zusammenfassung

Cardinal Health, Inc. is seeking a senior Regulatory Affairs & Product Development professional to lead regulatory submissions and strategy across drug, biologic, and device development.

You will oversee eCTD filings, ensure compliance with NDAs/ANDAs/MAAs, and liaise with Health Authorities worldwide. The role requires strong communication, risk management, and cross-functional teamwork within a global healthcare environment.

Qualifikationen

• 7+ years of hands-on regulatory affairs experience in pharma (drug/biologic).
• Bachelor's degree or equivalent; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes.
• Excellent knowledge of regulatory and cGMP requirements in sterile injectable and oral products.
• European drug applications experience preferred.
• Regulatory affairs input to cross-functional teams and vendor meetings.
• Excellent written and verbal communication; capable of presenting to regulators.
• Proficiency with Microsoft Office applications; able to document and manage filings.
• Diplomacy and negotiation skills; able to work independently and in teams.
• Occasional travel ~10%
• Regulatory Affairs Certification preferred.

Aufgaben

• Authorship/review of eCTDs for US and international submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with approval conditions of NDAs/ANDAs/MAAs/DMFs.
• Oversee risk management and change control across product lifecycles.
• Provide regulatory guidance for manufacturing sites (Cardinal Health facilities, CMOs, labs).
• Manage communications with regulatory agencies and participate in inspections.
• Provide RA input to program/project teams and cross-functional meetings.

Kenntnisse

Regulatory affairs

Regulatory strategy

eCTD submissions

NDAs/ANDAs/MAAs

cGMP compliance

Health Authority interactions

Microsoft Office

Ausbildung

Bachelor's degree

Advanced degree desirable

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking a senior Regulatory Affairs & Product Development professional to lead regulatory submissions and strategy across drug, biologic, and device development.

You will oversee eCTD filings, ensure compliance with NDAs/ANDAs/MAAs, and liaise with Health Authorities worldwide. The role requires strong communication, risk management, and cross-functional teamwork within a global healthcare environment.