Director - Global Regulatory Lead

October 1

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

501 - 1000

Description

• The Director, Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory strategies • Manage regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product • Provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met • Interface with business partners regarding global development, regulatory, and registration strategies • Supports the preparation and submission of global regulatory documentation to support investigational and marketing registration packages

Requirements

• BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry • 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge and substantial working experience • Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas • Prior experience with both small molecules and biologics • Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities • Strong business acumen and ability to make sound decisions that contribute positively to the business • Strong strategic skills including creativity and effectiveness in identifying and addressing strategic challenges

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness