Venesco, LLC

Senior Regulatory Affairs Scientist

Venesco, LLC  •  Falls Church, VA (Hybrid)  •  17 days ago
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Job 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)
Venesco, LLC

About Venesco, LLC

We have evolved over the past 18 years, starting as a small consulting business and emerging as a well-respected business specializing in biomedical R&D and IT support services.

Our success on federal initiatives is the product of our distinguished professional employees, agile management & quality processes, and financial aptitude. We have solid financials and mature processes, backed by our recognition in Inc. 5000 and Washington Technology's Fast 50 in 2017, 2018, 2019, 2020, and 2021. We possess a Top-Secret Facility Clearance and hold certifications for CMMI® Maturity Level 3 (ML3) for services and ISO 9001:2015 and 14001:2015.

Our 14 prime multiple-award IDIQ contracts have yielded a wealth of expertise in program, task order, and contract management worldwide. Venesco runs 65+prime contracts, ranging in size from as few as one or two employees to programs with 150+ employees. With over 350 credentialed employees, Venesco is a nimble small business with a large business impact and reach.

Industry
Aviation & Aerospace
Company Size
51-200 employees
Headquarters
Washington, District of Columbia
Year Founded
2004
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