SR Coordinator, Regulatory Submission Operations

Cardinal Health; United States; Remote; USD 37,000 - 48,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

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 is seeking a Senior Coordinator for Regulatory Submissions Operations. This remote role supports regulatory affairs and product development consulting services for pharmaceutical, medical and biotechnology clients, focusing on submission preparation and document management.

Responsibilities include formatting and editing documents, managing timelines, and coordinating with upstream and downstream partners.

Qualifications

• Experience formatting Microsoft Word documents is required.
• QA, QC, and SOP experience is a major plus.
• Experience in formatting and editing Adobe documents required.
• Familiarity with Excel required.
• Editorial and data analysis experience is a plus.
• Project management experience is a plus.
• Willingness to learn scientific principles.
• Attention to detail.
• Strong written and oral communication skills.

Responsibilities

• Assess and negotiate timelines.
• Manage client documents used in submissions.
• Process client documents within publishing software.
• Identify concerns and communicate with upstream and downstream partners.

Skills

Word formatting

QA/QC experience

Adobe formatting

Excel

Editorial data analysis

Project management

Scientific principles

Attention to detail

Communication skills

Job description

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by 50+ years of experience, with more than 50,000 employees in nearly 60 countries, Cardinal Health ranks among the top 20 on the Fortune 500. We boast tremendous opportunities to grow and apply technical skills to meet organizational needs, empowering talented team members who mentor and uplift others, led by leaders with a focus on employee development and well-being, dedicated training programs, and a collaborative atmosphere.

We currently have a career opening for a SR Coordinator Regulatory Submissions Operations Location Remote.

What Regulatory Submissions Operations contributes to Cardinal Health Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.

Regulatory Submissions Operations uses specialized technology and knowledge to format, edit and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development and though the drug product life cycle. This job family provides application submission and renewal services for state licensing activities, prepares specialized electronic files for drug registrations, drug listings and self-identification, and oversees and maintains document management databases for version and revision control.

Responsibilities

Regulatory Submissions Operations uses specialized technology and knowledge to format, edit and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development and through the drug product life cycle. This position provides application submission, prepares specialized electronic files for drug registrations, and oversees and maintains document management databases for version and revision control.

• Assess and negotiate timelines
• Manage client documents used in submissions
• Process client documents within publishing software
• Identify concerns and communicate with upstream and downstream partners

Qualifications

• Experience in advanced formatting of Microsoft Word documents is required.
• QA, QC, and SOP experience is a major plus
• Experience in formatting and editing Adobe documents required.
• Familiarity with Excel required.
• Editorial and data analysis experience is a plus.
• Project management experience is a plus.
• Willingness to learn scientific principles.
• Attention to detail
• Strong written and oral communication skills.

What is expected of you and others at this level

• Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments
• Applies advanced skills to resolve complex problems independently
• May modify process to resolve situations
• Works independently within established procedures; may receive general guidance on new assignments
• May provide general guidance or technical assistance to less experienced team members

Anticipated Pay Range

$27.00 - $34.56 per hour USD Bonus Eligible - No

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: 10/30/26

The hourly 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.

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.

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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.

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