Senior Regulatory Affairs Lead – Submissions & Strategy

Cardinal Health, Inc.; Colorado; On-site; USD 125,000 - 179,000; Full time

Benefits offered by this job

Medical, dental, vision

Paid time off

401k plan

HSA

Payroll flexibility

FSAs

Disability coverage

Work-life resources

Paid parental leave

Wellness programs

Job summary

Cardinal Health is seeking a seasoned Regulatory Affairs professional in the United States to lead eCTD submissions for INDs, NDAs, ANDAs and MAAs and to drive regulatory strategy across drug, biologic, and device development. You will interact with Health Authorities, manage inspections, and guide multi-disciplinary teams through lifecycle regulatory activities.

Requires 7+ years in regulatory affairs, strong communication, cGMP knowledge, and travel up to 10%.

Qualifications

• 7+ years of regulatory affairs hands-on experience in drug/biologic industry, including eCTD filings and regulatory strategy development.
• Bachelor's degree or equivalent in scientific/regulatory field; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes.
• Strong knowledge of regulatory and cGMP requirements (21 CFR parts).
• Experience with European drug applications preferred.
• Knowledge of radiopharmaceutical regulatory requirements preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Authorship/review of eCTDs for US submissions and external authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/DMF conditions.
• Lead risk management reviews across product lifecycles and change control processes.
• Provide regulatory guidance to manufacturing sites, CMOs, and labs.
• Interface with regulators; participate in inspections and meetings.
• Contribute RA input to cross-functional teams and vendor meetings.

Skills

Regulatory affairs

eCTD submissions

Regulatory strategy

Risk management

Change control

Communication skills

cGMP knowledge

Regulatory communications

Regulatory certifications

Education

Bachelor's degree in scientific/regulatory field

Advanced degree desirable

Tools

Microsoft Office

Job description

Cardinal Health is seeking a seasoned Regulatory Affairs professional in the United States to lead eCTD submissions for INDs, NDAs, ANDAs and MAAs and to drive regulatory strategy across drug, biologic, and device development. You will interact with Health Authorities, manage inspections, and guide multi-disciplinary teams through lifecycle regulatory activities.

Requires 7+ years in regulatory affairs, strong communication, cGMP knowledge, and travel up to 10%.