Associate Director - Global Regulatory Lead

December 4

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

501 - 1000 employees

Founded 1961

Description

• Responsible for developing, implementing, and advising on global regulatory strategies. • Manage regulatory aspects of compounds through all development phases and life-cycle. • Provide leadership and strategic regulatory oversight for designated projects. • Interface with outside regulatory agencies and business partners.

Requirements

• Minimum 8 years of experience in the biotechnical or pharmaceutical industry. • Preferred experience as lead in Regulatory Affairs across two or more major geographic areas. • Sound understanding of drug development process and regulatory requirements. • Ability to develop global regulatory strategy applying INDs/CTAs, NDAs/BLAs/MAAs. • Proven ability to deliver on goals within a cross-functional team environment. • Excellent interpersonal, oral, and written communication skills. • Strong negotiating skills and ability to think creatively.

Benefits

• Comprehensive benefits package includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. • Participation in annual bonus plan for non-commercial roles. • Incentive compensation plan for commercial roles. • Opportunity to own shares of BeiGene Ltd. stock through discretionary equity awards. • Voluntary participation in Employee Stock Purchase Plan.