SR Coordinator Regulatory Submissions Operations

Cardinal Health

Northern (KY)

Hybrid

USD 36,000 - 47,000

Full time

7 days ago
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Benefits offered by this job

Medical, dental, vision
Paid time off
Health savings account
401k plan
MyFlexPay access
FSAs
Disability coverage
Wellness programs
Parental leave
Lifestyle programs

Job summary

Cardinal Health is seeking a Sr Coordinator Regulatory Submissions Operations for remote work. The role focuses on formatting, editing, and compiling documents for regulatory submissions across drug development and lifecycle.

Responsibilities include managing timelines, handling client documents in submissions, and coordinating with upstream/downstream partners. Emphasis on attention to detail and strong communication skills; medical/pharma experience preferred.

Qualifications

  • Experience in advanced formatting of Microsoft Word documents is required.
  • Experience in formatting and editing Adobe documents required.
  • Familiarity with Excel required.
  • Publishing experience in eCTD preferred.
  • Project management experience is a plus.
  • 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

Attention to detail
Communication skills
Project management

Tools

Excel
Adobe
eCTD publishing

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 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.

Additional responsibilities include:
  • 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.
  • Experience in formatting and editing Adobe documents required.
  • Familiarity with Excel required.
  • Publishing experience in eCTD preferred.
  • Project management experience is a plus.
  • 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

$26.30 - $33.75 per hour USD Bonus Eligible - No 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: 9/14/26

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.

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.

To read and review this privacy notice click here

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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