Senior Regulatory Affairs Leader Submissions and Strategy

Cardinal Health, Inc.; Maryland; Vor Ort; 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 with my

Flexible spending accounts (FSAs)

Disability coverage

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 strategy for drug, biologic, and device development in the US and internationally.

You will author/review eCTDs, interact with Health Authorities, manage risk across product lifecycles, and advise on manufacturing regulatory requirements. Role requires 7+ years in regulatory affairs, strong communication skills, and familiarity with global regulatory guidance.

Qualifikationen

• 7+ years of regulatory affairs hands-on experience in pharma/biologic industries.
• Bachelor's degree or equivalent in scientific or regulatory field; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes (face-to-face, teleconference, emails).
• Strong knowledge of regulatory and cGMP requirements including 21 CFR parts applicable to sterile injectables and oral capsules.
• Experience with European drug applications (NA, MRP, DP, CP) preferred.
• Excellent verbal and written communication skills and ability to prepare technical documents and regulator communications.
• Proficient with Microsoft Office and regulatory filing software.

Aufgaben

• Authorship or review of eCTDs for US and outside-US submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/IND/MAA/DMF requirements and changes.
• Lead or participate in risk management reviews and change control processes.
• Provide regulatory guidance for manufacturing sites, CMOs, and labs.
• Manage communications with regulatory agencies and participate in inspections.
• Contribute RA input to cross-functional teams and vendor meetings.

Kenntnisse

Regulatory affairs

eCTD submissions

Regulatory strategy

FDA regulatory

European submissions

cGMP knowledge

Technical writing

Diplomacy

Regulatory Affairs Certification

Communication skills

Ausbildung

Bachelor's degree or equivalent

Advanced degree desirable

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking a Senior Regulatory Affairs professional to lead regulatory submissions and strategy for drug, biologic, and device development in the US and internationally.

You will author/review eCTDs, interact with Health Authorities, manage risk across product lifecycles, and advise on manufacturing regulatory requirements. Role requires 7+ years in regulatory affairs, strong communication skills, and familiarity with global regulatory guidance.