Senior Regulatory Affairs Leader – Submissions & Strategy

Cardinal Health, Inc.; USA; Remote; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision coverage

401k savings plan

Paid time off

Zusammenfassung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs and Product Development professional to drive regulatory submissions and strategy across drug, biologic, and device development from discovery through post-approval maintenance.

The role involves leading eCTD creation for US and international submissions, ensuring compliance with NDA/ANDA/MAA/NDS conditions, and guiding cross-functional teams through lifecycle management and regulatory inspections. Travel up to 10% is anticipated.

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.
• Excellent knowledge of regulatory and cGMP requirements (21 CFR parts) for sterile injectables and oral capsules.
• Direct interface with Health Authorities via multiple modes (face-to-face, teleconferencing, emails).
• Diplomacy and negotiation skills; ability to work independently or in a team.

Aufgaben

• Authorship/review/oversight of eCTDs for US and outside-US submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/NDS conditions of approval.
• Lead risk management reviews across product life cycles and change control processes.
• Provide regulatory guidance for manufacturing sites, CMOs, and labs.
• Manage communications with regulatory agencies and participate in inspections.

Kenntnisse

Regulatory strategy

Risk management

Cross-functional collaboration

Verbal and written communication

Diplomacy and negotiation

Ausbildung

Bachelor's degree in scientific or regulatory field

Advanced degree desirable

Tools

Microsoft Office

Drug application management software

Jobbeschreibung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs and Product Development professional to drive regulatory submissions and strategy across drug, biologic, and device development from discovery through post-approval maintenance.

The role involves leading eCTD creation for US and international submissions, ensuring compliance with NDA/ANDA/MAA/NDS conditions, and guiding cross-functional teams through lifecycle management and regulatory inspections. Travel up to 10% is anticipated.