Regulatory Affairs Generalist

Regulatory Affairs Generalist

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.