Remote Regulatory Affairs Manager

Cardinal Health, Inc.; Cheyenne (WY); Remote; USD 125,000 - 179,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. is seeking a senior Regulatory Affairs professional to lead eCTD submissions and regulatory strategy across pharma, biologics, and device development.

You will interface with Health Authorities, manage lifecycle regulatory tasks, and guide cross-functional teams in manufacturing and testing vendor meetings. Ideal candidates have 7+ years in regulatory affairs, a scientific/regulatory degree, and strong communication, diplomacy, and project leadership skills.

Qualifications

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical (drug and/or biologic) industry required, including but not limited to management and authorship of eCTD filings for INDs, NDAs, ANDAs, MAAs, and DMFs, regulatory strategy development, risk management, and change control participation.
• 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).
• Regulatory Affairs Certification preferred.

Responsibilities

• 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 conditions of approval of NDAs, ANDAs, MAAs and NDSs
• Oversee and perform risk management reviews through products' life cycles and participate in change management internal processes, such as engineering and documentation change control and cross-functional project meetings
• Provide guidance regarding regulatory requirements for manufacturing sites, encompassing Cardinal Health facilities, CMOs, and contract laboratories
• Managing communication with regulatory agencies, such as managing on site/remote meetings, participating in regulatory inspections, and representing the company as required
• Providing regulatory affairs input into program/project teams as required. Participate in and represent RA in cross-functional teams and with manufacturing and testing vendor meetings, as assigned.

Skills

Regulatory affairs

Communication skills

Diplomacy and negotiation

Independent & team work

Travel

Education

Bachelor's degree or equivalent in scientific/regulatory field

Advanced degree desirable

Job description

Cardinal Health, Inc. is seeking a senior Regulatory Affairs professional to lead eCTD submissions and regulatory strategy across pharma, biologics, and device development.

You will interface with Health Authorities, manage lifecycle regulatory tasks, and guide cross-functional teams in manufacturing and testing vendor meetings. Ideal candidates have 7+ years in regulatory affairs, a scientific/regulatory degree, and strong communication, diplomacy, and project leadership skills.