New · posted Nov 11
Cardinal Health · Pharmaceuticals
Manager, Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Manager
The role
What Regulatory Affairs and Product Development contributes to Cardinal Health
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.
What you need
Accountabilities
- 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
- 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
Bonus eligible: Yes
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
- 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
Application window anticipated to close: 1/10/2027 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
What you'll do
- 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.
Pay and benefits
$125,300 – $178,900 a year
Employer providedAnticipated salary range: $125,300.00-$178,900.00
Medical, dental and vision coverage
Paid time off plan
401k savings plan
Health savings account (HSA)
Paid parental leave
Short- and long-term disability coverage
Equal opportunity, accessibility and legal noticesCardinal Health's statements, word for word
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 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.
To read and review this privacy notice click here
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in the US23 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $125,300 | — | $178,900 |
| All US (middle half) | $151,250 | $160,000 | $171,000 |
This role: Cardinal Health's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 173 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Cardinal Health's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 43 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Documentation and SOPs5
- Regulatory submissions5
- GMP and compliance3
- Lab testing and methods3
- Quality systems and risk2
- Data and digital systems2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Affairs work in pharmaceuticals, led by the five this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissionsNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Cardinal Health on Regulatory Jobs
- 38
- Open roles
- 38
- Distinct roles
- 21
- Locations
By discipline
- Quality32 84%
- Regulatory5 13%
- Clinical1 3%
By level
- Senior & Principal23 61%
- Manager7 18%
- Associate & Specialist6 16%
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Manager, Regulatory Affairs at Cardinal Health
Open until filled. $125K–$179K a year, employer provided.