Manager, Regulatory Affairs

About the role

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.

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; identify 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
• Manage communication with regulatory agencies, including managing on-site/remote meetings, participating in regulatory inspections, and representing the company as required
• Provide 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
• Apply advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
• Participate in the development of policies and procedures to achieve specific goals
• Recommend new practices, processes, metrics, or models
• Work on or lead complex projects of large scope with significant and long-term impact
• Provide solutions which may set precedent; independently determine method for completion of new projects
• Receive guidance on overall project objectives
• Act as a mentor to less experienced colleagues

Qualifications

• 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, regulatory strategy development, risk management, and change control participation
• Bachelor's degree or equivalent experience in scientific or regulatory field preferred; advanced degree desirable
• Documented direct interface with Health Authorities via multiple modes (face-to-face, teleconference, 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 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 (National, MRP, DCP, 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

Pay

Anticipated salary range: $125,300.00–$178,900.00. Bonus eligible: Yes. Pay is determined by multiple factors including geographical location, relevant education, experience, skills, and internal pay equity.

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