Remote Regulatory Affairs Manager (Drug & Biologics)

Cardinal Health, Inc.; Austin (TX); Remote; 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 an experienced Regulatory Affairs professional to drive eCTD authorship and regulatory submissions across US and international authorities. You will shape regulatory strategy for drug development and ensure lifecycle compliance for NDAs, ANDAs, MAAs and DMFs.

The role requires deep knowledge of cGMP, strong communication, and the ability to lead cross-functional teams while interfacing with Health Authorities. Travel up to 10% may be necessary.

Qualifikationen

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical (drug and/or biologic) industry required, including management and authorship of eCTD filings for INDs, NDAs, ANDAs, MAAs, and DMFs.
• Bachelor's degree or equivalent in scientific or regulatory field preferred. Advance degree desirable.
• Documented direct interface with Health Authorities via multiple modes (face-to-face, T-con, and emails).
• Excellent knowledge of regulatory and cGMP requirements, including 21 CFR Part 11, Part 210, Part 211, Part 212, Part 314, and other relevant parts.
• Prior work experience with European drug applications (NA, MRP, DP, CP) strongly preferred.
• Knowledge of regulatory requirements as they apply to radiopharmaceuticals preferred.
• Excellent verbal and written communication skills, including authoring technical documents, and developing presentations.
• Proficient with Microsoft Office and able to manage drug applications.
• Diplomacy and negotiation skills; ability to take unpopular decisions.
• Ability to work independently and as part of a team; occasional travel – 10% or less.
• Regulatory Affairs Certification preferred

Aufgaben

• Authorship and/or review and oversight of creation of eCTDs for drug submission to US and outside-US Health Authorities
• Support regulatory strategy for drug development
• Ensure compliance with NDAs, ANDAs, MAAs and NDSs
• Oversee risk management reviews through products' life cycles and participate in change control processes
• Provide regulatory guidance for manufacturing sites, CMOs, and contract labs
• Manage communication with regulatory agencies including on-site/remote meetings and inspections
• Provide regulatory input into program/project teams and cross-functional meetings

Kenntnisse

Regulatory affairs

eCTD filings

Regulatory strategy

Ausbildung

Bachelor's degree or equivalent

Jobbeschreibung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to drive eCTD authorship and regulatory submissions across US and international authorities. You will shape regulatory strategy for drug development and ensure lifecycle compliance for NDAs, ANDAs, MAAs and DMFs.

The role requires deep knowledge of cGMP, strong communication, and the ability to lead cross-functional teams while interfacing with Health Authorities. Travel up to 10% may be necessary.