Senior Regulatory Affairs Leader - Global Submissions & Strategy

Regulatory Toolkit; USA; Remote; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision coverage

Paid time off

401k savings plan

HSA

Flex spending accounts

Disability coverage

Work-Life resources

Paid parental leave

Wellness programs

Zusammenfassung

Cardinal Health is seeking an experienced Regulatory Affairs professional to lead eCTD filings, shape regulatory strategy, and ensure compliance across drug, biologic and device programs. You will coordinate with health authorities, manage inspections, and guide cross-functional teams through lifecycle changes.

The role requires a strong background in US regulatory requirements, excellent communication skills, and the ability to operate in a fast-paced environment with occasional travel.

Qualifikationen

• Requires 7+ years in regulatory affairs with hands-on eCTD filings.
• Bachelor-level science degree; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes is expected.

Aufgaben

• Authorship/review of eCTDs for NDAs, ANDAs, MAAs, and DMFs.
• Support regulatory strategy for drug development.
• Ensure compliance with approval conditions of NDAs, ANDAs, MAAs, and NDSs.
• Lead risk management reviews and participate in change control processes; guide regulatory paths.

Kenntnisse

Regulatory strategy

eCTD authoring

FDA interactions

cGMP knowledge

Regulatory submissions

Communication skills

Ausbildung

Bachelor's degree in science

Advanced degree desirable

Tools

eCTD software

Microsoft Office

Jobbeschreibung

Cardinal Health is seeking an experienced Regulatory Affairs professional to lead eCTD filings, shape regulatory strategy, and ensure compliance across drug, biologic and device programs. You will coordinate with health authorities, manage inspections, and guide cross-functional teams through lifecycle changes.

The role requires a strong background in US regulatory requirements, excellent communication skills, and the ability to operate in a fast-paced environment with occasional travel.