What Regulatory Submissions Operations contributes to Cardinal Health
Regulatory Submissions Operations provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. More specifically, this role serves the function to support global, post-approval lifecycle regulatory requirements for Biologics and small-chemical entity pharmaceuticals. This function applies subject matter expertise to provide services in technical writing, scientific data verification, and basic regulatory submissions within the discipline of chemistry, manufacturing, and controls (CMC).

The Sr. Coordinator, Regulatory Submissions Operations will use 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 individual 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 - Open to candidates nationwide, fully remote (work from home)

Responsibilities

Work independently with minimal supervision once work is assignedAttend ad hoc and scheduled client meetings as requiredProactively work to support client workstreams Raise concerns immediately with ManagementMonitor progress for client work (update internal and external project trackers)

Qualifications

Meticulous attention to detailAbility to manage multiple large and small pharmaceutical data setsAbility to switch between projects with competing prioritiesAbility to adhere to internal and client timelinesExcellent communication skills (verbal and written); both to Management and peersProficiency with basic computer systems

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 assignmentsApplies advanced skills to resolve complex problems independentlyMay modify process to resolve situationsWorks independently within established procedures; may receive general guidance on new assignmentsMay provide general guidance or technical assistance to less experienced team members

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Anticipated hourly range: $25.20 per hour - $34.40 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 coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programs

Application window anticipated to close: 09/01/2025 *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.

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