Senior Regulatory Affairs Manager - Submissions & Strategy

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account

401k savings plan

Access to wages before pay day with my

Job summary

Cardinal Health, Inc. seeks an experienced Regulatory Affairs professional to lead submissions and strategic regulatory activities for drug, biologic, and device development from discovery through post-approval maintenance.

The role emphasizes eCTD authorship, regulatory strategy, and close collaboration with cross-functional teams. You will manage communications with health authorities, support inspections, and guide manufacturing sites and CMOs on regulatory requirements.

Qualifications

• 7+ years hands-on regulatory affairs in pharma with eCTD filings.
• Experience with INDs, NDAs, ANDAs, and DMFs and regulatory strategy.
• Strong written and verbal communication with health authorities.

Responsibilities

• Authorship/review of eCTDs for US and non-US submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA approvals.
• Coordinate with agencies and participate in inspections.
• Provide RA input to cross-functional teams.

Skills

Regulatory affairs

eCTD filings

Regulatory strategy

Risk management

Communication skills

Project management

Team collaboration

Education

Bachelor's degree

Tools

Regulatory software

Job description

Cardinal Health, Inc. seeks an experienced Regulatory Affairs professional to lead submissions and strategic regulatory activities for drug, biologic, and device development from discovery through post-approval maintenance.

The role emphasizes eCTD authorship, regulatory strategy, and close collaboration with cross-functional teams. You will manage communications with health authorities, support inspections, and guide manufacturing sites and CMOs on regulatory requirements.