Randstad Life Sciences US ยท 2 days ago
Regulatory Affairs Senior Associate
Thousand Oaks, CA
Full-time
Remote
Entry, Mid Level
2+ years exp
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Responsibilities
Manage regulatory document tracking systems
Support clinical trial and marketing activities
Assist with regulatory application submissions and communications with health authorities
Ensure compliance with SOPs and regulatory standards
Serve as the primary point of contact for data management between Regulatory, CMC representatives, publishing teams, and vendors
Manage Protocol Amendment New Investigator (PANI) submissions
Update PI information
Provide training, mentoring, and support to Data Management team members and other functions, including vendors
Collaborate closely with external partners and outsourced CROs
Qualification
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Required
Master's degree (MS) degree OR
Bachelor's degree (BS) and two (2) years' experience OR
Associate's degree (AS) and six (6) years of experience OR
High school diploma / GED and eight (8) years of experience
Experience with SharePoint, Excel, Smartsheet, and Veeva Vault.
Excellent communication skills and ability to work closely with stakeholders
Ability to work independently and handle multiple priorities
Preferred
Experience managing content in SharePoint
Working experience with the Six Sigma methodology
Process mapping and project management experience
Regulatory affairs knowledge will be considered.
Any Regulatory certifications/qualifications will add value.
Technical understanding of Regulatory systems will be desirable.
Knowledge and interest in SQLs/Databases will also be considered.
Company
Randstad Life Sciences US
Randstad North America, Inc. is a wholly-owned subsidiary of Randstad N.V., the world's largest HR services provider.
Deerfield, IL
1,001-5,000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase
