Regulatory Affairs Ops Specialist I
Round Lake, Illinois
Employer: Experis
Industry:
Salary: Competitive
Job type: Part-Time
Hello,
Title: Regulatory Affairs Ops Specialist I
Location : Round Lake IL
Contract
JD
• Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types
o Creating timelines for regulatory filings
o Providing and maintain templates for authoring.
o Overseeing authoring and reviewing of regulatory documents
o QC submission documents
• Contribute to the development of process improvements and procedural documents.
• Identifying and assessing regulatory risks and risks to timelines.
• Providing regulatory updates to the project team on different milestones.
• Working cross functionally with project management, operations, IT and other functions.
• Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents.
• Working closely with other members of the Regulatory team and provide support to their projects as needed.
• Maintaining archival of submissions and health authority communications in Veeva RIM system.
• Provide regulatory representation on key meetings, including meetings with health agency.
What do you bring:
• Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
• Strong organization skills and the ability to track multiple timelines in parallel and manage deadlines.
• Excellent written and verbal communication and ability to collaborate across functions.
• Experience with Veeva Vault systems is preferred.
• Strong team player, self-motivated and able to function independently as well as part of a team
• Able to work on multiple projects concurrently and adapt to a continuously changing environment.
• BA/BS in a scientific field and 2-4 years of proven experience
Title: Regulatory Affairs Ops Specialist I
Location : Round Lake IL
Contract
JD
• Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types
o Creating timelines for regulatory filings
o Providing and maintain templates for authoring.
o Overseeing authoring and reviewing of regulatory documents
o QC submission documents
• Contribute to the development of process improvements and procedural documents.
• Identifying and assessing regulatory risks and risks to timelines.
• Providing regulatory updates to the project team on different milestones.
• Working cross functionally with project management, operations, IT and other functions.
• Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents.
• Working closely with other members of the Regulatory team and provide support to their projects as needed.
• Maintaining archival of submissions and health authority communications in Veeva RIM system.
• Provide regulatory representation on key meetings, including meetings with health agency.
What do you bring:
• Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
• Strong organization skills and the ability to track multiple timelines in parallel and manage deadlines.
• Excellent written and verbal communication and ability to collaborate across functions.
• Experience with Veeva Vault systems is preferred.
• Strong team player, self-motivated and able to function independently as well as part of a team
• Able to work on multiple projects concurrently and adapt to a continuously changing environment.
• BA/BS in a scientific field and 2-4 years of proven experience
Created: 2024-06-20
Reference: 318183
Country: United States
State: Illinois
City: Round Lake
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