Senior Regulatory Affairs Manager – Drug & Device Submissions

Cardinal Health; Juneau (AK); Vor Ort; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical coverage

PTO

HSA

401k

Flexible work options

Life and disability insurance

Zusammenfassung

Cardinal Health is seeking a regulatory affairs professional to support and consult on regulatory submissions for drug, biologic, and device development from discovery through post-approval. You will author/review eCTDs for US and international health authorities and contribute to regulatory strategy for development programs.

The role involves ensuring compliance with approvals, leading risk assessments, and guiding manufacturing sites and external partners.

Qualifikationen

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical or biologic industry.
• Experience with eCTD filings for INDs, NDAs, ANDAs, MAAs, and DMFs.
• Knowledge of regulatory requirements and cGMP including 21 CFR parts.

Aufgaben

• Authorship/review of eCTD filings for US and outside-US health authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA approvals and post-approval requirements.
• Oversee risk management reviews across product lifecycles and change control processes.
• Provide regulatory guidance for manufacturing sites, CMOs, and laboratories.
• Manage communications with regulatory agencies and participate in inspections.

Jobbeschreibung

Cardinal Health is seeking a regulatory affairs professional to support and consult on regulatory submissions for drug, biologic, and device development from discovery through post-approval. You will author/review eCTDs for US and international health authorities and contribute to regulatory strategy for development programs.

The role involves ensuring compliance with approvals, leading risk assessments, and guiding manufacturing sites and external partners.