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US Regulatory Lead

Thinkbyte Consulting, Inc.United States🇺🇸United StatesPosted 25 Aug 2026

Why This Role Stands Out

This hybrid role offers a fantastic opportunity to lead US regulatory strategy and submissions within a respected consulting firm, fostering significant career growth and skill development in oncology and neurology. You'll thrive here if you possess strong FDA regulatory knowledge and a passion for driving impactful projects within a collaborative environment. This is an excellent chance to advance your career with a company known for its expertise.

Quick Overview

Seniority
Mid Senior
Work mode
Hybrid
Location
United States
Posted
2 weeks ago
ComplianceDocument ManagementPharmacyRegulatory Compliance

Job Description

Key Responsibilities & Skills
  • US FDA Regulatory Requirements
  • IND / NDA / BLA Submission Management
  • Regulatory Research & Intelligence
  • Cross-Functional Team Representation
  • Process Mapping & Authoring for Submissions
  • External Innovation Assessment (Regulatory)
  • Oncology & Neurology Therapeutic Knowledge
  • Project Deliverable Coordination
  • Regulatory Strategy Development
  • US Regulatory Compliance
Technical Skills
  • eCTD / FDA Submission Portal
  • Regulatory Intelligence Tools
  • Document Management Systems
Education

Bachelor's Degree (BS/BA) in Pharmacy, Pharmacology, Biology, Chemistry, Biomedical Sciences. Preferred: Master's Degree (MS), PhD, PharmD, MBA.

Industry Experience
  • Pharmaceuticals
  • Oncology
  • Neurology
  • Clinical Development
  • Regulatory Affairs

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