What are the responsibilities and job description for the Regulatory Associate position at System One?
Title: Regulatory Associate
Location: Consumer Goods company in Princeton, NJ 08543
Employment type: 1 year contract
Hours/Shift: Monday - Friday 8:30 - 4:30
Schedule: Hybrid (Monday & Friday remote | Tuesday-Thursday onsite)
Pay Rate – hourly: $40-45 per hour
Must Haves/Requirements:
Top 3-4 Skills/Experience:
Regulatory Associate
Job description / Responsibilities:
Minimum Requirements
Ref: #101-All Depts
Location: Consumer Goods company in Princeton, NJ 08543
Employment type: 1 year contract
Hours/Shift: Monday - Friday 8:30 - 4:30
Schedule: Hybrid (Monday & Friday remote | Tuesday-Thursday onsite)
Pay Rate – hourly: $40-45 per hour
Must Haves/Requirements:
Top 3-4 Skills/Experience:
- BS Degree in Sciences required
- 5 years of experience in regulatory required
- Experience working with FDA Industry System’s FURLS account including CDER, CFSAN and CDRH export certification and tracking systems desired but not required.
- Experience as a notary public is a plus, but not required
- Experience with MS Suite required (company has outlook, Teams, Word, Excel, etc.)
Regulatory Associate
- The Regulatory Associate handles tasks to support regulatory processes/projects and may lead a minimal complexity project. This position prepares regulatory analyses and summaries. This position works primarily within the Regulatory Department.
- Regulatory Affairs Associate will work in a cross-functional environment to support the obtaining and maintaining of legalized documents for global product registrations. RA associate will monitor, track and report progress to the regional RA team and maintains registration databases ensuring the accurate documentation is available for registrations.
Job description / Responsibilities:
- Request US export certificates from State or Federal government agencies or trade associations legalization of documents (notary, apostille, consularization) required for global product registrations (APAC, EMEA and LATAM)
- Coordinate with cross-functional teams for the required information to process the documents
- Ensure completed and accurate regulatory export documents are scanned and uploaded to the database
- Maintain legalization tracker to track export certificates and ensure delivery of original documents to regional offices
- Maintain registration request database ensuring that records are accurate and current
- Coordinate with regional regulatory partners for registration information and provide timely updates to them
- Maintain work instructions and templates
- Support legalization of regional ancillary documents
- Other regulatory projects as assigned
Minimum Requirements
- 5 years of relevant experience required
- Bachelor’s degree in a scientific filed or technical discipline preferred
- Working knowledge of Microsoft office (Outlook, Word, Excel, PowerPoint), SharePoint, MS Teams
- Notary Public is a plus
- Experience working with FDA Industry System’s FURLS account including CDER, CFSAN and CDRH export certification and tracking systems desired but not required.
Ref: #101-All Depts
Salary : $40 - $45
