Sr. Coordinator, Regulatory Submission Operations - Remote Eligible

Regulatory Submissions Operations

Regulatory Submissions Operations provides regulatory affairs and product development consulting services to enable pharmaceutical, medical, and biotechnology companies to obtain regulatory approvals. This role supports 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 through 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 assigned
• Attend ad hoc and scheduled client meetings as required
• Proactively work to support client workstreams
• Raise concerns immediately with Management
• Monitor progress for client work (update internal and external project trackers)

Qualifications

• Meticulous attention to detail
• Ability to manage multiple large and small pharmaceutical data sets
• Ability to switch between projects with competing priorities
• Ability to adhere to internal and client timelines
• Excellent communication skills (verbal and written); both to Management and peers
• Proficiency 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 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 hourly range: $25.20 per hour - $34.40 per hour

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: 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.