Regulatory Affairs Generalist

*
* 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…