Senior Regulatory Affairs Lead – Drug & Device Submissions

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

Benefits dieser Stelle

Medical, dental and vision coverage

Paid time off

401k savings plan

HSA

Flexible spending accounts

Short- and long-term disability

Work‑Life resources

Paid parental leave

Healthy lifestyle programs

Zusammenfassung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support regulatory submissions and product development across pharma, biologics, and devices.

The role requires 7+ years in regulatory affairs, with strong experience in eCTD filings, regulatory strategy, and cross-functional collaboration. Travel up to 10% may be required; a Bachelor's degree is essential, with advanced degrees preferred.

Qualifikationen

• 7+ years of hands-on regulatory affairs experience in pharma including eCTD filings for INDs/NDAs/ANDAs/MAAs/DMFs, regulatory strategy, risk management and change control.
• 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, email).
• Excellent knowledge of regulatory and cGMP requirements (21 CFR parts 11, 210-212, 314, etc.) for sterile injectables and oral products.
• Experience with European drug applications (NA, MRP, DP, CP) preferred.
• Knowledge of radiopharmaceutical regulatory requirements is a plus.
• Excellent verbal and written communication; ability to author technical docs and regulatory correspondence; proficient with MS Office.
• Diplomacy, negotiation skills, independent and team-oriented work style; travel up to 10%.

Aufgaben

• Authorship and/or review of eCTDs for US and external Health Authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/NDS conditions.
• Lead risk management reviews across product life cycles and participate in change control.
• Provide regulatory guidance for Cardinal Health facilities, CMOs, and contract labs.
• Manage communication with regulatory agencies and participate in inspections.
• Provide RA input to program teams and participate in cross-functional vendor meetings.

Kenntnisse

Regulatory affairs

eCTD filings

Regulatory strategy

Risk management

Documentation

Cross-functional teams

Regulatory inspections

Ausbildung

Bachelor's degree

Advanced degree desirable

Tools

eCTD management

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support regulatory submissions and product development across pharma, biologics, and devices.

The role requires 7+ years in regulatory affairs, with strong experience in eCTD filings, regulatory strategy, and cross-functional collaboration. Travel up to 10% may be required; a Bachelor's degree is essential, with advanced degrees preferred.