Remote Senior Regulatory Affairs Manager

Cardinal Health, Inc.; Phoenix (AZ); Remote; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

MyFlexPay wage access

Zusammenfassung

Cardinal Health, Inc. is seeking a Regulatory Affairs professional with 7+ years of hands-on regulatory experience in the pharmaceutical industry. You will oversee eCTD submissions, regulatory strategy, and lifecycle management across NDAs, ANDAs, MAAs, and DMFs, ensuring compliance and successful interactions with Health Authorities.

The role requires strong communication and project management skills, with travel as needed. Competitive benefits and a comprehensive salary range are offered.

Qualifikationen

• 7+ years of hands-on regulatory affairs in pharma (drug/biologic) industry.
• Bachelor’s degree or equivalent in scientific/regulatory field; 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).
• Experience with European drug applications (NA, MRP, DP, CP) preferred.
• Excellent verbal and written communication skills.

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/NDS conditions.
• Oversee risk management reviews through product life cycles and change control processes.
• Provide regulatory guidance for manufacturing sites (Cardinal Health facilities, CMOs, contract labs).
• Manage communication with regulatory agencies and participate in inspections.

Kenntnisse

Regulatory affairs

Communication skills

Project management

Team collaboration

Attention to detail

Ausbildung

Bachelor's degree in scientific or regulatory field

Advanced degree desirable

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking a Regulatory Affairs professional with 7+ years of hands-on regulatory experience in the pharmaceutical industry. You will oversee eCTD submissions, regulatory strategy, and lifecycle management across NDAs, ANDAs, MAAs, and DMFs, ensuring compliance and successful interactions with Health Authorities.

The role requires strong communication and project management skills, with travel as needed. Competitive benefits and a comprehensive salary range are offered.