Regulatory Affairs Lead – Drug & Device Submissions

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

HSA and FSAs

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to lead eCTD authoring and regulatory submissions for drugs, biologics, and devices. You will support regulatory strategy, ensure compliance with NDA/ANDAs/MAAs, and manage agency communications across product lifecycles.

The role requires strong written and verbal communication, robust cross‑functional collaboration, and eligibility for regulatory inspections. Occasional travel is expected as part of duties.

Qualifications

• 7+ years regulatory affairs hands‑on experience in the pharmaceutical/biologic industry.
• Bachelor's degree or equivalent in scientific or regulatory field; advanced degree desirable.
• Documented interface with Health Authorities via multiple modes (face‑to‑face, conference calls, emails).
• Excellent knowledge of regulatory and cGMP requirements as applied to injectable/oral products.
• Prior work with European drug applications (NA, MRP, DP, CP) preferred.
• Knowledge of radiopharmaceutical regulatory requirements is a plus.
• Strong written/verbal communication and ability to present to regulators.

Responsibilities

• Authorship and review of eCTDs for US and international submissions.
• Support regulatory strategy for drug development programs.
• Ensure compliance with approval conditions of NDAs, ANDAs, MAAs, and DMFs.
• Lead risk management reviews across product life cycles and change control.
• Provide regulatory input to manufacturing sites, CMOs, and testing vendors.
• Manage communications with regulatory agencies and participate in inspections.
• Contribute RA input to program/project teams and cross‑functional meetings.

Skills

Regulatory affairs expertise

Regulatory strategy development

Communication skills

Project management

Team collaboration

Travel readiness

Education

Bachelor's degree or equivalent in scientific/regulatory field

Advanced degree desirable

Regulatory Affairs Certification preferred

Tools

eCTD authoring tools

Microsoft Office

Regulatory databases

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to lead eCTD authoring and regulatory submissions for drugs, biologics, and devices. You will support regulatory strategy, ensure compliance with NDA/ANDAs/MAAs, and manage agency communications across product lifecycles.

The role requires strong written and verbal communication, robust cross‑functional collaboration, and eligibility for regulatory inspections. Occasional travel is expected as part of duties.