Senior Regulatory Affairs Manager

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

Benefits offered by this job

Medical, dental & vision

Paid time off

Health savings account

401k plan

Flexible spending accounts

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to lead regulatory submissions for drugs, biologics, and devices from discovery through post-approval.

The role involves eCTD authorship, strategy development, and cross-functional collaboration across manufacturing and QA teams. The ideal candidate has 7+ years in regulatory affairs, strong communication, and a track record with Health Authorities.

Qualifications

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical/biologic industry.
• Excellent verbal and written communication skills, including authoring technical documents for regulators.
• Diplomacy and negotiation skills with the ability to lead complex discussions.

Responsibilities

• Authorship/review/oversight of eCTDs for US and international submissions.
• Support regulatory strategy for drug development projects.
• Ensure compliance with NDA/IND/MAA filings and regulatory requirements.

Skills

Regulatory affairs

Communication

Negotiation

Teamwork

Regulatory guidance

Education

Bachelor's degree

Advanced degree desirable

Tools

MS Office

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to lead regulatory submissions for drugs, biologics, and devices from discovery through post-approval.

The role involves eCTD authorship, strategy development, and cross-functional collaboration across manufacturing and QA teams. The ideal candidate has 7+ years in regulatory affairs, strong communication, and a track record with Health Authorities.