Senior Regulatory Affairs Scientist

Venesco

Falls Church, VA

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JOB DETAILS

SKILLS

Biology, Cross-Functional, Documentation, FDA Requirements, ICH Regulations, IDE (Integrated Development Environment), Maintain Compliance, Medical Products, Monitor Regulations, New Drug Application, Regulations, Regulatory Compliance, Regulatory Submissions, Strategic Planning

LOCATION

Falls Church, VA

POSTED

2 days ago

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)

About the Company

Venesco

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