Senior Regulatory Affairs Consultant – Regulatory Lead
Parexel
Global Regulatory Affairs Associate
Eurofins
full-time
Posted on:
Location Type: Remote
Location: Remote • Missouri • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
AssemblyVault
About the role
- Prepare submissions in eSubmitter or relevant Agency web-based systems.
- Provide electronic document importing support and archiving for VMRD.
- Upload electronic documents and respective metadata into Veeva Vault.
- Review documents to ensure submission quality.
- Perform page merge/extractions using PDF and zip files.
- Perform and complete document Information checks for documents signed within Veeva Vault.
- Assist as necessary with ordering, securing, and archiving Literature References for regulatory submissions.
Requirements
- E-submitter experience preferred or related web-based agency submission system.
- Substantial working knowledge and experience with electronic document management systems in a regulatory corporate setting.
- Expertise with Microsoft Word, Excel, and Adobe Acrobat.
- Assist with the assembly and document sourcing in support with Agency (FDA, EPA) submissions (e.g. A&P, NCIEs, CMC).
- Assemble and submit regulated Agency documents, to tight deadlines and high-quality standards, using the department’s submission publishing systems.
- Adhere to the appropriate use of the submission publishing and document management systems, through use of working practices such that regulatory compliance is preserved.
- Work with the submission publishing team to ensure that all assigned submission requirements and timelines are mutually understood and in line with corporate standards and deadlines for submission delivery.
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Bachelors or Masters Degree in Biological or Chemical Science.
Benefits
- Excellent full time benefits including comprehensive medical coverage
- dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Career Development and continuing education opportunitie
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
eSubmitterelectronic document management systemsMicrosoft WordMicrosoft ExcelAdobe Acrobatdocument assemblydocument sourcingsubmission publishing systemsdocument quality reviewmetadata management
Soft skills
attention to detailtime managementcommunicationcollaborationorganizational skills
