Regulatory Affairs Lead — Drug Submissions & Strategy

Cardinal Health, Inc.; Connecticut; 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

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 seasoned Regulatory Affairs professional to lead eCTD submissions, develop regulatory strategies for drug development, and ensure compliance across NDA/ANDA/MAA programs. You will interact with Health Authorities and guide cross-functional teams through product lifecycles.

The role requires strong communication skills and experience with international regulatory activities, including regulatory inspections and site guidance.

Qualifications

• 7+ years of regulatory affairs hands-on experience in pharma (drug/biologic).
• Bachelor's degree or equivalent in scientific or regulatory field; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes.
• Expertise in regulatory and cGMP requirements (21 CFR Parts).
• Experience with European drug applications preferred.
• RAC certification preferred.

Responsibilities

• Authorship/review/oversight of eCTDs for US/foreign submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/DMF conditions.
• Provide regulatory input to program/project teams.

Skills

Regulatory strategy

eCTD filings

Regulatory inspections

Cross-functional collaboration

Communication skills

Agency interfacing

Education

Bachelor's degree or equivalent

Advanced degree desirable

Regulatory certification (RAC) preferred

Tools

Microsoft Office

Job description

Cardinal Health, Inc. is seeking a seasoned Regulatory Affairs professional to lead eCTD submissions, develop regulatory strategies for drug development, and ensure compliance across NDA/ANDA/MAA programs. You will interact with Health Authorities and guide cross-functional teams through product lifecycles.

The role requires strong communication skills and experience with international regulatory activities, including regulatory inspections and site guidance.