Executive Director, Regulatory Affairs, Solid Tumor Lead

1 month ago

Emeryville, California, United States BeiGene Full time
Job Title: Executive Director, Regulatory Affairs, Solid Tumor Lead

The Executive Director, Regulatory Affairs, Solid Tumor Lead will be responsible for managing a team of regulatory affairs professionals within the solid tumor franchise and supporting the development of North America strategy across the solid tumor programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders.

Key Responsibilities:
  • Manage a team of regulatory affairs professionals responsible for the regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product.
  • Provide leadership, guidance, and strategic regulatory oversight for the solid tumor portfolio ensuring that the latest requirements and standards are met while leveraging expedited pathways where appropriate.
  • Act as an advisor/liaison to the NA project leaders and project teams to support the planning, evaluation, and recommendation of regulatory strategy.
  • Develop and implement regulatory processes and procedures to ensure compliance with regulatory requirements.
  • Recruit, develop, manage, and mentor regulatory professionals and help create a goal-oriented culture.
Requirements:
  • BA/BS Degree with 14 plus years of experience in the biotechnical or pharmaceutical industry, and a minimum of 12 years' experience in a Regulatory capacity with a broad background.
  • Extensive experience working with the US FDA in the oncology therapeutic area.
  • Thorough understanding of drug development process and the pharmaceutical industry including regulatory requirements and policy trends.
  • Ability to identify and proactively respond to emerging regulatory trends anticipating future challenges and opportunities in strategy.
  • 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 major strategic challenges and opportunities to expedite development and regulatory processes.
Preferred Qualifications:
  • Advanced degree preferred.
  • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
  • Strong people management skills, able to encourage, support, and empower a team of NA strategists.
  • Excellent interpersonal, oral, and written communication skills.
  • Ability to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.

BeiGene is an equal opportunity employer and welcomes applications from diverse candidates.

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