Executive Director, Regulatory Affairs - Solid Tumor Lead

September 27

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

501 - 1000 employees

Founded 1961

Description

• Responsible for managing a team of NA leaders • Supporting the development of North America Strategy • Managing regulatory aspects of compounds through all phases of development • Providing leadership, guidance and strategic regulatory oversight • Ensuring the latest regulatory requirements and standards are met • Supporting planning, evaluation and recommendation of regulatory strategy • Training, developing, and managing an effective regulatory team • Building partnerships with key stakeholders

Requirements

• Bachelor’s degree in a science related curriculum required • 14 plus years of experience in the biotechnical or pharmaceutical industry • Minimum of 12 years’ experience in a Regulatory capacity • Extensive experience working with the US FDA in the oncology therapeutic area • Thorough understanding of drug development process and the pharmaceutical industry • Expert in US FDA strategy development and execution • Strong business acumen and ability to make sound decisions • Excellent interpersonal, oral and written communication skills

Benefits

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