Regulatory Affairs Associate Job at Alexander Technology Group, Portsmouth, NH

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  • Alexander Technology Group
  • Portsmouth, NH

Job Description

Alexander Technology Group is working with a Medical Device client looking to hire a Regulator Affairs Associate to join their team.

This is an on-site position in Portsmouth, NH

Regulatory Affairs Associate – Combination Products

We seek a detail-oriented Regulatory Affairs Associate to support New Drug Application (NDA) content development for combination products. This role focuses on regulatory documentation, compliance, and collaboration with cross-functional teams.

Key Responsibilities:

  • Draft, edit, and format NDA content for combination products.
  • Compile and organize submission data.
  • Conduct quality reviews for accuracy and compliance.
  • Manage version control and document timelines.
  • Stay updated on combination product regulations.

Qualifications:

  • Bachelor’s degree in life sciences, pharmacy, engineering, or related field.
  • Strong writing, formatting, and attention to detail.
  • Knowledge of combination product regulations (FDA guidelines).
  • Proficiency in document management and MS Office.
  • Ability to work independently and in cross-functional teams.

Preferred Skills:

  • Experience in regulatory submissions or medical writing.
  • Familiarity with eCTD, NextGen portal, and design control regulations (21 CFR Part 820).

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