Senior Regulatory Affairs Leader - Drug & Device Submissions

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short‑ and long‑term disability

Work‑Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. seeks a Regulatory Affairs and Product Development professional to lead regulatory submissions across drug, biologic, and device development from discovery through post-approval maintenance. You will manage eCTD authorship and review for US and international submissions and contribute to regulatory strategy.

Anticipated salary range: $125,300.00-$178,900.00. Bonus eligible. Requires excellent communication, leadership and ability to work with cross-functional teams; travel

Qualifications

• 7+ years of hands-on regulatory affairs experience in pharma/biologics
• Bachelor's degree or equivalent in scientific/regulatory field preferred; advanced degree desirable
• Direct interface with Health Authorities via multiple modes
• Excellent knowledge of regulatory and cGMP requirements (21 CFR parts)
• Experience with European drug applications (NA, MRP, DP, CP) preferred
• Knowledge of radiopharmaceutical regulatory requirements desirable
• Excellent verbal and written communication; capable of authoring technical documents and regulators' correspondence

Responsibilities

• Authorship/review/oversight of eCTDs for US and outside-US submissions
• Support regulatory strategy for drug development
• Ensure compliance with approval conditions for NDAs, ANDAs, MAAs, etc.
• Lead or participate in risk management reviews across product life cycles
• Provide regulatory guidance for manufacturing sites and CMOs/contract labs
• Manage communications with regulatory agencies and inspections
• Contribute RA input to cross-functional teams and vendor meetings

Skills

Regulatory affairs

eCTD filings

Regulatory strategy

Risk management

Communication skills

Leadership

Education

Bachelor's degree or equivalent

Advanced degree desirable

Tools

Microsoft Office

Job description

Cardinal Health, Inc. seeks a Regulatory Affairs and Product Development professional to lead regulatory submissions across drug, biologic, and device development from discovery through post-approval maintenance. You will manage eCTD authorship and review for US and international submissions and contribute to regulatory strategy.

Anticipated salary range: $125,300.00-$178,900.00. Bonus eligible. Requires excellent communication, leadership and ability to work with cross-functional teams; travel