Regulatory Affairs Operations Specialist

Job Description

Job Description

Kelly Science & Clinical is seeking a  Regulatory Affairs Operations Specialist near Bridgewater, NJ.

 

6 month contract position

Shift: Monday - Friday 8am-5pm

Compensation: $50-$60/hr DOE

 

Responsibilities:

• Responsible for publishing regulatory submissions in various formats including eCTD/NeeS, performing quality control reviews of publishing outputs, and dispatching submissions to the relevant Health Authorities including the US FDA and Health Canada.
• Responsible for preparing, dispatching and archiving 2253 submissions for OPDP.
• Communicating with RA Strategy and/or CMC Leads to ensure content accuracy and identify issues that could be incompliant with health authority guidance or impact compliance timelines.
• Ensuring final documents are submission-ready and compliant with applicable health authority requirements while addressing any advanced document or technical issues as needed.
• Archiving regulatory submissions and related correspondence in accordance with established archiving and document retention strategies and maintaining accurate records in RIM systems.
• Assisting in development and maintenance of Regulatory Operations best practices and contributing to process improvements to enhance efficiency and quality.
• Performing other responsibilities as assigned.

 

Qualifications:

• Experienced technical skills for the preparation, publishing, and archiving of regulatory documents including tracking the status in RIM systems such as Veeva RIM.
• Knowledgeable about the FDA and Health Canada eCTD submissions lifecycle management, as well as the associated guidance, specifications, and regulations.
• Proficient in eCTD format and regulatory submission requirements.
• Working knowledge of document management systems and regulatory publishing tools, preferably with Veeva RIM and docuBridge.
• Ability to balance multiple tasks while meeting priorities and timelines.
• Experienced in leading the management of submissions and timelines and collaborating with team members.
• Demonstrate strong communication skills and the ability to work effectively within a team.
• A minimum of 3 years of combined pharmaceutical and regulatory experience.
• Bachelor’s degree preferred.

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.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.