ASSOCIATE, REGULATORY AFFAIRS (1077907)

Location: Morris, NJ

Salary: $80,000.00 USD Annually - $120,000.00 USD Annually

Description: Our client is currently seeking a Regulatory Affairs Associate. This is a permanent, direct hire role in Morris County, NJ.

Summary

• Assist in preparing and submitting high-quality regulatory documents (ANDAs, NDAs, Amendments, Supplements, Annual Reports) to the FDA.
• Gather and review technical documentation for compliance.
• Draft clear, concise responses to FDA inquiries.
• Track submissions and maintain regulatory databases.
• Assess regulatory changes and their business impact.
• Handle and document regulatory agency communications.
• Perform additional duties as assigned.
  
  

Qualifications

• Bachelor’s degree in life sciences.
• 3 years in pharma, including 1-2 in regulatory affairs.
• Strong communication, analytical, and organizational skills.
• Knowledge of FDA guidelines.
• Detail-oriented, ethical, and able to manage multiple tasks efficiently.
  
  

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Contact: jgood@judge.com

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