Regulatory Operations Associate I (West Coast)
About The Position
Premier Research is looking for a Regulatory Operations Associate I (West Coast) to join our Regulatory Operations team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.
Requirements
- Bachelor’s degree, or international equivalent from an accredited institution, in Science/Technology, or an equivalent combination of education and experience
- 2-4 years of Regulatory Operations experience within the pharmaceutical or biotech industry
- Basic to Intermediate experience using Microsoft Office and Adobe Professional
- Ability to appropriately handle confidential and highly sensitive material
Responsibilities
- Create and format various basic to intermediate documents, utilizing internal processes and tools to perform the activities pertaining to electronic publishing and to meet required standards and technical requirements within specified timelines
- Electronically publish components of Regulatory Agency submissions, including INDs and amendments, annual reports, safety reports, etc.
- Work with relevant internal staff to ensure that source documents are received in a timely manner in order to support the generation of submissions
- Perform the QC for all applications, amendments and supplements prior to submitting to Agency
- Perform quality checks of others’ work
- Participate in the implementation of new health agency guidelines and rules relevant to regulatory submissions
- Participate in department projects that improve the department systems and processes
- Assist in the review of Regulatory Operations work practices
- Interact with clients, as needed
Benefits
- health insurance
- life insurance
- retirement plan
- paid time off
- Employee Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
251-500 employees
