Regulatory Affairs Generalist

Job Description

Job Description

Location: Bridgewater, NJ

Kelly® Science & Clinical is seeking a Regulatory Affairs Generalist for a contract opportunity supporting our client in the life sciences industry. If you’re experienced in preparing FDA submission materials, committed to accuracy and regulatory compliance, and thrive in a fast-paced, professional environment, trust The Experts at Hiring Experts to guide your next career move.

Position Overview

In this role, you will provide hands-on regulatory writing, document review, proofreading, and quality-control support for FDA submissions across investigational and marketed products. You will collaborate with Regulatory Affairs leadership and cross-functional subject matter experts to help ensure submission documents are accurate, complete, and prepared in accordance with applicable regulatory requirements.

Key Responsibilities

• Prepare, review, proofread, and quality-check components of FDA submissions for IND, NDA, and ANDA products.
• Author and support regulatory documentation, including cover letters, FDA forms, Module 1 documents, annual reports, labeling, non-CMC supplements, and product correspondence.
• Support development of modular submission content contributed by nonclinical, clinical, medical affairs, and other subject matter experts.
• Partner with Regulatory Management to ensure product documentation aligns with regulatory requirements throughout the product lifecycle.
• Assist with documentation and materials required for interactions with regulatory authorities.
• Deliver final submission-ready documents to Regulatory Operations for e-publishing and submission in eCTD format .
• Communicate progress, potential timeline risks, and regulatory concerns to Regulatory Product Leads and/or Regulatory Affairs leadership.
• Contribute to special projects and continuous process-improvement initiatives as assigned.

Qualifications

• Associate degree required; bachelor’s degree preferred, or equivalent relevant experience.
• At least 1.5 years of Regulatory Affairs experience or relevant experience in a regulated environment.
• Working knowledge of pharmaceutical Regulatory Affairs across product development, labeling, and post-market activities.
• Familiarity with U.S. and international regulatory laws, regulations, and guidance.
• Understanding of clinical development and regulatory requirements supporting development milestones and market authorization.
• Experience with Microsoft Word, Excel, Adobe Acrobat Pro, and eCTD submission-format requirements.
• Experience with a controlled document management system; Documentum experience is preferred .
• Strong attention to detail, proofreading ability, analytical reasoning, and critical-thinking skills.
• Clear written and verbal communication skills, with the ability to collaborate effectively across teams.
• Ability to assess project risks, escalate concerns appropriately, and respond decisively in changing circumstances.

Interested candidates should apply directly to this job posting.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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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