Senior Regulatory Affairs Leader for Drug & Device Submissions

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

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off plan

Health savings account (HSA)

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs and Product Development professional to lead regulatory submissions and strategy across drug, biologic, and device development stages.

The role focuses on authoring/reviewing eCTDs for US and international authorities, ensuring compliance with NDA/ANDA/MAA requirements, and providing RA input in cross-functional teams and with manufacturing and testing vendors. Travel up to 10% may be required.

Qualifications

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical industry.
• Experience managing eCTD filings for INDs, NDAs, ANDAs, MAAs, and DMFs; regulatory strategy development.
• Excellent knowledge of 21 CFR Part 11, 210, 211, 212, 314, and related guidance for sterile injectable drug and oral capsule manufacturing.
• Direct interface with Health Authorities via multiple modes (face-to-face, teleconference, emails).
• Diplomacy and negotiation skills; ability to work independently and in teams.

Responsibilities

• Authorship and/or review of eCTDs for US and outside-US Health Authorities
• Support regulatory strategy for drug development
• Ensure compliance with NDA/ANDA/MAA/NDs requirements
• Oversee risk management reviews through product life cycles and change control processes
• Provide regulatory guidance for Cardinal Health facilities, CMOs, and contract labs
• Manage communications with regulatory agencies and participate in inspections
• Contribute RA input to cross-functional teams and vendor meetings

Skills

Regulatory affairs

eCTD submissions

Regulatory strategy

Risk management

Scientific writing

Communication skills

Microsoft Office

Team collaboration

Travel readiness

RA Certification preferred

Education

Bachelor's degree or equivalent in scientific/regulatory field

Advanced degree desirable

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs and Product Development professional to lead regulatory submissions and strategy across drug, biologic, and device development stages.

The role focuses on authoring/reviewing eCTDs for US and international authorities, ensuring compliance with NDA/ANDA/MAA requirements, and providing RA input in cross-functional teams and with manufacturing and testing vendors. Travel up to 10% may be required.