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Kelly Science & Clinical is seeking a Regulatory Affairs Ops Specialist near Round Lake, IL.

Long term contract = 1 year contract

Shift: Monday - Friday 1st

Hybrid - 3 days onsite, 2 remote

Compensation : based on experience

Responsibilities:

• Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission typeso Creating timelines for regulatory filingso Providing and maintain templates for authoring.o Overseeing authoring and reviewing of regulatory documentso 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.

Qualifications:

• BA/BS in a scientific field and 2-4 years of proven experience

• 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.