Remote Regulatory Affairs Manager

Cardinal Health, Inc.; Bismarck (ND); On-site; 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 Regulatory Affairs professional to lead eCTD submissions and regulatory strategy for drug and biologic development from discovery through post-approval maintenance.

You will guide cross-functional teams, manage regulatory submissions, and ensure compliance with NDAs/ANDAs/MAAs/DMFs, liaising with Health Authorities as needed. Strong communication and regulatory expertise are required.

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 experience 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 required of regulatory and cGMP requirements, including in 21 CFR Part 11, Part 210, Part 211, Part 212, Part 314, and other relevant 21 CFR parts and regulatory guidance documents as applied to a sterile injectable drug and oral capsule manufacturing environment.
• Prior work experience with European drug applications (NA, MRP, DP, CP) strongly preferred.
• Knowledge of regulatory requirements as they apply to radiopharmaceuticals preferred. Familiarity with nuclear product development, injectable drug products desirable.
• Excellent verbal and written communication skills, including authoring technical documents, authoring correspondence with regulators, and developing and delivering effective presentations.
• Proficient with Microsoft Office software (word processor, spreadsheet, presentation, calendar etc) and able to use software for managing drug applications.
• Diplomacy and negotiation skills, as well as the confidence to take unpopular decisions.
• Ability to work both independently and as a member of a team, smoothly transitioning between the two.
• Occasional travel – 10% or less
• 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. This includes identifying optimal scientific and technical paths and regulatory filing routes (e.g. PAS, CBE, or AR in US).
• Provide guidance regarding regulatory requirements for manufacturing sites, encompassing Cardinal Health facilities, contract manufacturing organizations (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 strategy

eCTD filings

Regulatory submissions

Risk management

Cross-functional collaboration

Regulatory inspections

Education

Bachelor's degree or equivalent in scientific or regulatory field

Advanced degree desirable

Tools

Microsoft Office

Job description

Cardinal Health, Inc. is seeking a Regulatory Affairs professional to lead eCTD submissions and regulatory strategy for drug and biologic development from discovery through post-approval maintenance.

You will guide cross-functional teams, manage regulatory submissions, and ensure compliance with NDAs/ANDAs/MAAs/DMFs, liaising with Health Authorities as needed. Strong communication and regulatory expertise are required.