Director - Global Regulatory Lead

October 21

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Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO

501 - 1000 employees

Founded 1961

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