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22040, Falls Church, VA
Senior Regulatory Affairs Scientist

Sonic Summary

The position is for a Senior Regulatory Affairs Scientist in a hybrid work environment.
Candidates should have an advanced degree in regulatory science, biology, or a related field.
A minimum of 8 years of regulatory affairs experience is required for this role.
The role involves preparing and submitting INDs, NDAs, BLAs, and IDEs, as well as serving as the primary liaison with the FDA.
While the salary is not explicitly mentioned, preferred qualifications include RAC certification and experience with electronic submissions (eCTD).

Description

Senior Regulatory Affairs Scientist

Location: Hybrid
Job Type: Full-Time

About the Role

Join a dynamic regulatory team as a Senior Regulatory Affairs Scientist, where you will lead submission strategies and regulatory interactions for innovative medical products.

Key Responsibilities

Develop and execute regulatory strategies and submission plans
Prepare and submit INDs, NDAs, BLAs, and IDEs
Serve as primary liaison with FDA and regulatory agencies
Provide regulatory guidance to cross-functional teams
Monitor regulatory trends and ensure compliance with evolving requirements
Review and approve regulatory documentation

Requirements

Qualifications

Advanced degree in regulatory science, biology, or related field
8+ years of regulatory affairs experience
Strong knowledge of FDA regulations and ICH guidelines

Preferred

RAC certification
Experience with electronic submissions (eCTD)

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