Senior Regulatory Affairs Manager – Drug & Device Submissions

Cardinal Health, Inc.; Texas; Vor Ort; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings 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

Zusammenfassung

Cardinal Health, Inc. is seeking a senior Regulatory Affairs professional to lead regulatory submissions and provide strategic support for drug, biologic, and device development.

You will craft eCTDs for US and international health authorities, guide regulatory strategy, and ensure compliance across NDA/ANDA/MAA filings throughout product life cycles. The role requires extensive experience with regulatory filings, cross-functional collaboration, and strong communication with authorities.

Qualifikationen

• 7+ years of regulatory affairs hands-on experience in pharma/biologic industries.
• Bachelor's degree in scientific or regulatory field; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes.
• Strong knowledge of regulatory and cGMP requirements (21 CFR parts).
• Experience with European drug applications preferred.
• Knowledge of radiopharmaceutical regulatory requirements preferred.
• Excellent written and verbal communication; ability to author technical docs.
• Proficient with Microsoft Office and regulatory filing tools.
• Diplomacy and negotiation skills; ability to work independently.
• Occasional travel up to 10%.

Aufgaben

• Authorship/review and oversight of eCTDs for US and outside-US health authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/NDS conditions of approval.
• Oversee risk management reviews across product lifecycles; advise on filing routes.
• Provide regulatory guidance for Cardinal Health sites, CMOs, and labs.
• Manage communications with regulatory agencies; participate in inspections.
• Provide RA input into program teams and cross-functional meetings.

Kenntnisse

Regulatory affairs

eCTD filings

Regulatory strategy

FDA interactions

cGMP knowledge

Ausbildung

Bachelor's degree

Advanced degree desirable

Regulatory Affairs Certification preferred

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking a senior Regulatory Affairs professional to lead regulatory submissions and provide strategic support for drug, biologic, and device development.

You will craft eCTDs for US and international health authorities, guide regulatory strategy, and ensure compliance across NDA/ANDA/MAA filings throughout product life cycles. The role requires extensive experience with regulatory filings, cross-functional collaboration, and strong communication with authorities.