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Kelly Services Regulatory Affairs Specialist in Madison, New Jersey

Regulatory Affairs Specialist

Kelly Science and Clinical is currently recruiting for a qualified, full-time, fully-benefited, Regulatory Specialist in Madison, NJ for one of our clients. The need to fill this position is immediate and is a long-term contract assignment. The position is a part of the Animal Health Research and Development division in the Global Regulatory Affairs department of a highly reputable company. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Summary of the Position:

The Specialist will work as part of a global regulatory team and be responsible to track information in the registration database and communicate with stakeholders. This person will track the submissions and approvals by entering Chemistry, Manufacturing, and Control (CMC) parameters to be tracked into the database

Responsibilities:

  • Assist with migration activities as well as verification of information for the registration database

  • Assist with collecting additional information for the registration database

  • Responsible for tracking of regulatory submissions and approvals as well as the communication of the outcome of submissions to stakeholders

  • Responsible for variation/supplement entries

  • Provide support to others with respect to the registration database

  • Other tasks as needed

Qualifications/Education/Skills:

  • Bachelor’s degree in a scientific, regulatory, or business operations field required

  • Experience working in a regulated pharmaceutical organization preferred

  • Familiarity with the drug development and approval process within a regulatory function preferred

  • Experience with Veeva RIM system or other regulatory databases preferred

  • Previous big pharma experience a huge plus

  • Strong communication skills preferred

  • A COVID-19 Vaccination mandate requirement

Hours: This role is on-site in a hybrid model: 2 days on-site and 3 days remote; however, one of the on-site days must be Monday. During training, the candidate will be required to be on-site for training and then may move to a hybrid model thereafter.

This is a very exciting and collaborative opportunity to be a part of one of the top pharma companies in the world.

APPLY TODAY!!!

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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