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

V0dHVjkzdjZJdGxkUjVxU2JuQnFxQjZWQkE9PQ==
  • 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).

Job Tags

Similar Jobs

Pride Health

Radiologic Technologist Job at Pride Health

 ...insurance, critical illness insurance, and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance, and employee discounts with preferred vendors. #RadiologyJobs... 

Chewy Design Co.

Production Assistant - Custom Van Building Job at Chewy Design Co.

 ...and a passion for the road , weve built over 60 vans that reflect our clients unique lifestyles. Now, were looking for a Shop Assistant to keep our workspace running smoothly and gain hands-on experience in the van-building process. What Youll Do: &##128313;... 

LA Sports Report

Sports & Entertainment Writer - MLB, NBA, NFL - IN-PERSON LOS ANGELES OFFICE Job at LA Sports Report

 ...LA Sports Report is a dynamic publishing company based in the Los Angeles Metropolitan Area. We have recently expanded our cover to National...  ...production, and trend analysis for search engine and social media optimization. We are home to contributors from across the... 

The Kennickell Group

Commercial Sheetfed Offset Printing Press Operator Job at The Kennickell Group

Kennickell Group, Savannah since 1892 Experienced sheetfed offset printing First Pressman/Printing Press Operator Start Date: Before 8/31/24 Salary: Negotiable/Commensurate with experience Moving Allowance: Negotiable Description: Komori 640L (6 color + coating...

Get It - Executive

Inbound Call Center Agent Spanish/English Bilingual FT/PT - Remote | WFH Job at Get It - Executive

 ...in a fast-paced environment. If you're bilingual in Spanish and English, that's a plus! What You'...  ...year of call center experience, including working with an automatic dialer and call...  ...English bilingual is a plus Work-from-Home Requirements To succeed in this role...