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.
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.
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities.We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges – now, and in the future.As a global, growing company, we’re able to offer rewarding careers that let you make a positive impact on our customers and communities.