Regulatory Affairs Specialist Job Listing at Kelly Services in Bridgewater, NJ (Job ID US3580662_BH9888169)

Description

Regulatory Affairs Specialist 
Kelly Science and Clinical is seeking a Regulatory Affairs Specialist for our client a leading medical device company in Bridgewater, NJ.  If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Schedule: HYBRID 3 days on site 2 days remote
Shift: Monday through Friday day shift
Length of assignment: Six months
Pay: $37-$40 an hour

• Responsibilities
• Provide support for the execution of the pharmaceutical regulatory strategy and submissions for assigned products: Provide support for IND/NDA/ANDA submission activities as needed, eg., Labeling Supplement, Annual Report, Product Correspondence etc.
• Support regulatory aspects of product development team to make certain all product documentation is developed in accordance with regulatory requirements for agency filing
• Participate in product team meetings as needed and complete follow up actions.
• Support the preparation of documentation and materials required for meetings with Regulatory Authorities for assigned products Manage timely archival of Health Authority Correspondences at company designated location
• Demonstrated ability in analytical reasoning and critical thinking skills
• Qualifications: Bachelors degree required, in life sciences or health related disciplines preferred. Master s degree preferred
• 2+ years of relevant pharmaceutical industry and regulatory experience Knowledge of FDA regulations and guidance's
• Knowledge of pharmaceutical CMC, nonclinical, clinical development to support marketing authorization and/or lifecycle management Ability to partner within regulatory and with cross-functional teams in a pharmaceutical organization
• Ability to understand scientific information and assess whether technical arguments are articulated clearly
• Demonstrated ability in analytical reasoning and critical thinking skills
• Strong capability to contribute to a team environment
• Excellent communication skills; both oral and written Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
• What happens next
  Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry—even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
  Helping you discover what's next in your career is what we're all about,

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 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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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 participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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