Senior Regulatory Affairs Manager – Remote

Cardinal Health, Inc.; Annapolis (MD); Remote; 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. is seeking a regulatory affairs professional to support drug, biologic and device development with filings for US and international authorities.

You will oversee eCTD creation, advise on regulatory strategy and ensure NDA/IND/ANDA/MAA/DMF compliance across product lifecycles. The role requires collaboration with manufacturing sites, CMOs, and testing labs, plus interaction with regulatory bodies and possible inspections.

Qualifications

• Excellent verbal and written communication skills, including authoring technical documents.
• Diplomacy and negotiation skills for regulatory discussions and cross-functional work.
• Bachelor's or higher degree in a scientific/regulatory field preferred.

Responsibilities

• Authorship/review/oversight of eCTDs for US and outside-US health authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/IND/ANDA/MAA/DMF conditions of approval.
• Lead risk management reviews through product life cycles and change control processes.
• Provide regulatory guidance for manufacturing sites including CMOs and labs.
• Manage communications with regulatory agencies and participate in inspections.

Skills

Regulatory communications

Project coordination

Negotiation skills

Education

Bachelor's degree in science/regulatory

Advanced degree desirable

Tools

Microsoft Office

Job description

Cardinal Health, Inc. is seeking a regulatory affairs professional to support drug, biologic and device development with filings for US and international authorities.

You will oversee eCTD creation, advise on regulatory strategy and ensure NDA/IND/ANDA/MAA/DMF compliance across product lifecycles. The role requires collaboration with manufacturing sites, CMOs, and testing labs, plus interaction with regulatory bodies and possible inspections.