Manager, Regulatory Affairs

Cardinal Health, Inc.; Austin (TX); Remote; USD 125,000 - 179,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to drive eCTD authorship and regulatory submissions across US and international authorities. You will shape regulatory strategy for drug development and ensure lifecycle compliance for NDAs, ANDAs, MAAs and DMFs.

The role requires deep knowledge of cGMP, strong communication, and the ability to lead cross-functional teams while interfacing with Health Authorities. Travel up to 10% may be necessary.

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.
• Bachelor's degree or equivalent 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 of regulatory and cGMP requirements, including 21 CFR Part 11, Part 210, Part 211, Part 212, Part 314, and other relevant parts.
• Prior work experience with European drug applications (NA, MRP, DP, CP) strongly preferred.
• Knowledge of regulatory requirements as they apply to radiopharmaceuticals preferred.
• Excellent verbal and written communication skills, including authoring technical documents, and developing presentations.
• Proficient with Microsoft Office and able to manage drug applications.
• Diplomacy and negotiation skills; ability to take unpopular decisions.
• Ability to work independently and as part of a team; occasional travel – 10% or less.
• Regulatory Affairs Certification preferred

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 NDAs, ANDAs, MAAs and NDSs
• Oversee risk management reviews through products' life cycles and participate in change control processes
• Provide regulatory guidance for manufacturing sites, CMOs, and contract labs
• Manage communication with regulatory agencies including on-site/remote meetings and inspections
• Provide regulatory input into program/project teams and cross-functional meetings

Skills

Regulatory affairs

eCTD filings

Regulatory strategy

Education

Bachelor's degree or equivalent

Job description

State Remote

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GA-Georgia-Work from Home

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DE-Delaware-Work from Home

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CO-Colorado-Work from Home

CA-California-Work from Home

AZ-Arizona-Work from Home

AR-Arkansas-Work from Home

AL-Alabama-Work from Home

AK-Alaska-Work from Home

ND-North Dakota-FIELD

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WV-West Virginia-Work from Home

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TN-Tennessee-Work from Home

Full time

20190303

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.

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.

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

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

Anticipated salary range:

$125,300.00-$178,900.00

Bonus eligible:

Yes

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

Application window anticipated to close:

1/10/2027

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.

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.

View Cardinal Health on YouTube (http://youtube.com/user/CardinalHealth)