Regulatory Affairs Generalist

Regulatory Affairs Generalist

Kelly® Science & Clinical is seeking a Regulatory Affairs Generalist for a contract opportunity supporting our client in Bridgewater NJ 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.

• Pay rate starting at $37.00 per hour perhaps some flexibility
• Hybrid work schedule - enjoy both onsite and remote flexibility
• Long-term contract opportunity through the end of 2027

What’s a typical day as Regulatory Affairs Generalist? You’ll be:

• Reviewing, proofreading, and quality-checking FDA submission components for IND, NDA, and ANDA products
• Authoring and supporting regulatory documentation, including cover letters, FDA forms, Module 1 documents, annual reports, labeling, non-CMC supplements, and product correspondence
• Preparing and reviewing modular submission content from nonclinical, clinical, and medical affairs subject matter experts
• Collaborating with Regulatory Management to ensure product documentation aligns with regulatory requirements
• Supporting preparation of materials for regulatory authority interactions
• Delivering final submission-ready documents for e-publishing and eCTD format submission
• Communicating progress, potential risks, and regulatory concerns to Regulatory Product Leads and/or Regulatory Affairs leadership
• Contributing to special projects and continuous process-improvement initiatives as assigned

This job might be an outstanding fit if you:

• Have at least an Associate degree; Bachelor’s degree is preferred or equivalent relevant experience
• Possess a minimum of 1.5 years of Regulatory Affairs experience or experience in a regulated environment
• Demonstrate working knowledge of pharmaceutical Regulatory Affairs across development, labeling, and post-market activities
• Are familiar with domestic and international regulatory laws, regulations, and guidance
• Understand clinical development and regulatory requirements for development milestones and market authorization
• Are proficient with Microsoft Word, Excel, Adobe Acrobat Pro, eCTD submission-format requirements, and controlled document management systems (Documentum experience preferred)
• Have excellent attention to detail, proofreading, analytical reasoning, and critical-thinking skills
• Communicate clearly both in writing and verbally, and collaborate effectively across teams
• Can assess project risks, escalate concerns appropriately, and respond decisively in changing circumstances

What happens next

Once you apply, you’ll proceed to 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, so let’s get to work. Apply to be Regulatory Affairs Generalist today!

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