Senior Regulatory Affairs Manager - Drug & Device Submissions

Cardinal Health, Inc.; Maine; 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

MyFlexPay

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Zusammenfassung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support drug, biologics, and device development from discovery through post-approval maintenance.

The role involves leading eCTD submissions to US Health Authorities, guiding regulatory strategy, ensuring post-approval compliance, and collaborating with cross-functional teams to advance products through development and lifecycle management.

Qualifikationen

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical industry with eCTD filings.
• Bachelor's degree or equivalent in scientific or regulatory field; an advanced degree is desirable.
• Direct interface with Health Authorities via multiple modes (face-to-face, teleconference, email).
• Strong knowledge of regulatory and cGMP requirements including 21 CFR parts relevant to sterile injectable and oral products.
• European drug applications experience (NA, MRP, DP, CP) is strongly preferred.
• Knowledge of radiopharmaceutical regulatory requirements and nuclear product development desirable.
• Excellent verbal and written communication skills for technical documents and regulator interactions.
• Proficiency with Microsoft Office and drug-application regulatory filing software.
• Occasional travel up to 10%.
• Regulatory Affairs Certification preferred.

Aufgaben

• Authorship and/or review of eCTDs for US and international submissions.
• Support regulatory strategy for drug development programs.
• Ensure compliance with approval conditions for NDAs/ANDAs/MAAs/DMFs.
• Lead or participate in risk management and change-control processes.
• Provide regulatory guidance for Cardinal Health facilities, CMOs, and labs.
• Interact with regulatory agencies and represent the company in inspections.
• Contribute RA input to cross-functional teams and vendor meetings.

Kenntnisse

Regulatory affairs

Regulatory strategy

Communication

Project management

Team collaboration

Ausbildung

Bachelor's degree in science/regulatory field

Regulatory Affairs Certification

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support drug, biologics, and device development from discovery through post-approval maintenance.

The role involves leading eCTD submissions to US Health Authorities, guiding regulatory strategy, ensuring post-approval compliance, and collaborating with cross-functional teams to advance products through development and lifecycle management.