Want to be a hands on contributor and responsible for the new drug application process? Keep reading now...

What Regulatory Affairs and Product Development contributes to Cardinal Health

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

Roles and 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.

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

What is expected of you and others at this level

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
• Participates in the development of policies and procedures to achieve specific goals
• Recommends new practices, processes, metrics, or models
• Works on or may lead complex projects of large scope
• Projects have significant and long-term impact
• Provides solutions which may set precedent
• Independently determines method for completion of new projects
• Receives guidance on overall project objectives
• Acts as a mentor to less experienced colleagues

Anticipated salary range: $97,700 -$150,000

Bonus eligible: Yes

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.