Regulatory Affairs Generalist

Position Title: Regulatory Affairs Generalist

Work Location: Bridgewater, NJ

Assignment Duration: 2 Months

Work Arrangement: Hybrid

• Hybrid work schedule-enjoy both onsite and remote flexibility
• Long-term contract opportunity through the end of 2027

Position Summary:

If you're experienced in preparing FDA submission materials, committed to accuracy and regulatory compliance, and thrive in a fast-paced, professional environment.

Key Responsibilities:

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  Reviewing, proofreading, and quality-checking FDA submission components for IND, NDA, and ANDA products

  
  
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  Authoring and supporting regulatory documentation, including cover letters, FDA forms, Module 1 documents, annual reports, labeling, non-CMC supplements, and product correspondence

  
  
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  Preparing and reviewing modular submission content from nonclinical, clinical, and medical affairs subject matter experts

  
  
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  Collaborating with Regulatory Management to ensure product documentation aligns with regulatory requirements

  
  
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  Supporting preparation of materials for regulatory authority interactions

  
  
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  Delivering final submission-ready documents for e-publishing and eCTD format submission

  
  
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  Communicating progress, potential risks, and regulatory concerns to Regulatory Product Leads and/or Regulatory Affairs leadership

  
  
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  Contributing to special projects and continuous process-improvement initiatives as assigned

  
  

Qualification & Experience:

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  Have at least an Associate degree; Bachelor's degree is preferred or equivalent relevant experience

  
  
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  Possess a minimum of 1.5 years of Regulatory Affairs experience or experience in a regulated environment

  
  
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  Demonstrate working knowledge of pharmaceutical Regulatory Affairs across development, labeling, and post-market activities

  
  
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  Are familiar with domestic and international regulatory laws, regulations, and guidance

  
  
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  Understand clinical development and regulatory requirements for development milestones and market authorization

  
  
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  Are proficient with Microsoft Word, Excel, Adobe Acrobat Pro, eCTD submission-format requirements, and controlled document management systems (Documentum experience preferred)

  
  
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  Have excellent attention to detail, proofreading, analytical reasoning, and critical-thinking skills

  
  
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  Communicate clearly both in writing and verbally, and collaborate effectively across teams

  
  
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  Can assess project risks, escalate concerns appropriately, and respond decisively in changing circumstances