Job Title : Regulatory Affairs Ops Specialist

Location : Round Lake, IL, 60073

Duration : 06 months

Summary :

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

About Us : Established in 2004, SPECTRA FORCE ® is one of the largest and fastest-growing diversity-owned staffing firms in the US.

The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.

I. proprietary talent acquisition platform, robust ISO 9001 : 2015 / ISO 27001 certified processes, and strong and passionate client engaged teams.

We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India.

Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation.

SPECTRA FORCE is built on a concept of human connection, defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential.

Learn more at : http : / / www.spectraforce.com

Benefits : SPECTRA FORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees.

Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program.

SPECTRA FORCE provides unpaid leave as well as paid sick leave when required by law.