Remote Regulatory Affairs Manager

Cardinal Health, Inc.; Dover (DE); Remote; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day

Zusammenfassung

Cardinal Health, Inc. is seeking a seasoned Regulatory Affairs professional to support regulatory submissions, strategy, and lifecycle management for pharmaceutical products.

You will lead eCTD activities, navigate global requirements, and collaborate with manufacturing, QA, and clinical teams to ensure compliant development and post-approval success. The role requires strong communication with Health Authorities, ability to manage complex filings, and willingness to travel up to 10% to support

Qualifikationen

• 7+ years of regulatory affairs hands-on experience in pharma (drug/biologic) industry.
• Experience with eCTD filings for INDs/NDAs/MAAs/DMFs and regulatory strategy.
• Strong knowledge of regulatory requirements and cGMP considerations.
• Proven communication skills with regulators and cross-functional teams.
• Willingness to travel ~10%.

Aufgaben

• Authorship/review of eCTD submissions to US and international Health Authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with approvals (NDAs/ANDAs/MAAs/DMFs).
• Lead risk management reviews and change control in collaboration with QA/Manufacturing.
• Provide regulatory input to program teams and attend vendor meetings.

Kenntnisse

Regulatory affairs

eCTD filings

Regulatory strategy

Communication skills

MS Office

Travel 10%

Ausbildung

Bachelor's degree or equivalent

Jobbeschreibung

Cardinal Health, Inc. is seeking a seasoned Regulatory Affairs professional to support regulatory submissions, strategy, and lifecycle management for pharmaceutical products.

You will lead eCTD activities, navigate global requirements, and collaborate with manufacturing, QA, and clinical teams to ensure compliant development and post-approval success. The role requires strong communication with Health Authorities, ability to manage complex filings, and willingness to travel up to 10% to support