Business Wire
Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO
501 - 1000
Director - Global Regulatory Lead
October 21
Business Wire
Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO
501 - 1000
Description
• Develops, implements, and advises on global regulatory strategies for development programs • Manages regulatory aspects of compounds through development, post-approval, and product lifecycle • Provides leadership and strategic regulatory oversight for designated projects • Supports the preparation and submission of global regulatory documentation • Maintains awareness of global regulatory environment and assesses impact of changes • Builds partnerships with key stakeholders to ensure strategic business goals are met • Mentors regulatory professionals and helps create a goal-oriented culture
Requirements
• BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years in biotechnical or pharmaceutical industry • 5+ years in a Regulatory capacity with broad and in-depth regulatory knowledge • Preferred: experience working as a lead in Regulatory Affairs across two or more major geographic areas • Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management • Strong business acumen and strategic skills including creativity and effectiveness in identifying challenges • Excellent interpersonal, oral and written communication skills • Strong PC literacy required; MSOffice skills
Benefits
• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness
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🇺🇸 United States – Remote
💵 $53.7k - $89.9k / year
💰 Post-IPO Debt on 2023-02
⏰ Full Time
🟡 Mid-level
🟠 Senior
🚔 Compliance
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