Remote Senior Regulatory Affairs Manager

Cardinal Health, Inc.; Richmond (VA); Remote; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical coverage

Dental coverage

Vision coverage

Paid time off

Health savings account

401k plan

Early wage access

Flexible spending accounts

Disability coverage

Work-life resources

Paid parental leave

Healthy lifestyle programs

Zusammenfassung

Cardinal Health, Inc. is seeking a senior Regulatory Affairs & Product Development professional in the United States to lead eCTD submissions and regulatory strategy for drug and biologic development from discovery through post-approval maintenance.

You will manage interactions with Health Authorities, oversee risk management, and mentor colleagues while supporting cross-functional teams and manufacturing partners; occasional travel up to 10%.

Qualifikationen

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical (drug and/or biologic) industry.
• Bachelor's degree or equivalent in scientific or regulatory field preferred; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes (face-to-face, T-con, emails).
• Excellent knowledge of regulatory and cGMP requirements (21 CFR parts).
• Occasional travel – 10% or less; regulatory certification preferred

Aufgaben

• Authorship and/or review of eCTDs for drug submissions to US and outside-US Health Authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/DMF approvals; participate in change control and cross-functional meetings.
• Provide regulatory input to program/project teams and cross-functional vendor meetings.
• Manage communication with regulatory agencies and participate in inspections.

Kenntnisse

eCTD submissions

Regulatory strategy

Risk management

Regulatory meetings

Cross-functional collaboration

Ausbildung

Bachelor's degree or equivalent

Advanced degree desirable

Jobbeschreibung

Cardinal Health, Inc. is seeking a senior Regulatory Affairs & Product Development professional in the United States to lead eCTD submissions and regulatory strategy for drug and biologic development from discovery through post-approval maintenance.

You will manage interactions with Health Authorities, oversee risk management, and mentor colleagues while supporting cross-functional teams and manufacturing partners; occasional travel up to 10%.