Sr. Coordinator, Regulatory Submissions Operations

Regulatory Submissions Operations

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 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. Location – Remote (nationwide) work from home, hours vary dependent on time zone of individual

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

Qualifications

Experience working with Microsoft Office (Word, etc) necessary for success in this role

Experience using Adobe (formatting, editing) a plus

Targeting individuals with a high level of attention to detail a requirement

Targeting individuals with strong communication skills (email, verbal), who take pride in producing high quality work, and aren't afraid to ask questions

Ideally targeting 2+ years of professional experience (background in publishing, editing, or regulatory a plus but not required)

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

What is expected of you and others at this level

Anticipated hourly range: $26.30 per hour – 33.10 per hour

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: 09/10/2025 if interested in opportunity, please submit application as soon as possible. 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.