[Hiring] Manager, Regulatory Affairs @Cardinal Health

Role Description

Regulatory Affairs & Product Development is responsible for regulatory affairs support and consulting to provide innovative solutions and regulatory submissions for all aspects of pharmaceutical, biologics and device development from discovery through post-approval maintenance.

• 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, 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

Qualifications

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical (drug and/or biologic) industry required
• 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
• 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 and correspondence with regulators
• Proficient with Microsoft Office software 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
• Occasional travel – 10% or less
• Regulatory Affairs Certification preferred

Requirements

• Independently determines method for completion of new projects
• Receives guidance on overall project objectives
• Acts as a mentor to less experienced colleagues

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs