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Senior Specialist, Regulatory Affairs
Job in
Summit, Union County, New Jersey, 07902, USA
Listed on 2026-10-08
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-08
Job specializations:
-
Healthcare
Healthcare Compliance -
Pharmaceutical
Healthcare Compliance
Job Description & How to Apply Below
Senior Specialist, Regulatory Affairs, providing expertise in regulatory compliance strategies for biopharma products.
Responsibilities:- develop and review regulatory documents (CTDs)
- ensure compliance with US and international health authority requirements
- assist in regulatory strategy development
- monitor evolving regulations
- Bachelor's or Master’s in life sciences, with 7+ or 5+ years of regulatory compliance experience in pharmaceutical drug development; experience with US and international submissions preferred.
- strong knowledge of FDA, ICH guidelines, project management, document organization, and effective communication.
- focus on immunotherapies, cell therapies, or biologics in development stages, with experience in regulatory submissions and compliance for marketed and pipeline products.
Collaboration with scientific and regulatory teams.
Work setup:Work setup: full-time, predominantly desk-based; no specific travel requirements stated.
This opportunity is for the Senior Specialist, Regulatory Affairs role at Scorpion Therapeutics.
Position Requirements
10+ Years
work experience
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