Executive Director, Regulatory Affairs, Solid Tumor Lead

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

The Executive Director, Solid Tumor North America Lead will be responsible for managing a team of NA leaders 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. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of at least 2 strategist) who are responsible for the regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product. The incumbent will 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.

The individual will have regulatory affairs and cross-functional influence within the solid tumor development portfolio and will act as an advisor/liaison to the NA project leaders and project teams to support the planning, evaluation and recommendation of regulatory strategy. The individual will have extensive experience with the United States FDA, oncology division, leading key interactions including supporting advisory committee (ODAC) meetings, will have had people management experience and a reputation of collaborative approach when interfacing with business partners regarding development, regulatory, and registration strategies. He/she will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.

Responsibilities:

• Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically and operationally to support the development of the solid tumor portfolio and projects, and regulatory issues to support corporate goals.
• Provides high level strategic and operational regulatory direction and leadership on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory strategic development plans and risk assessments, critical issue management and advice on FDA interactions.
• Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to support investigational and marketing registration packages within the US and Canada.
• Supports the NA solid tumor regional team to negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
• Maintains awareness of the US regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of these regulations.
• Integrates functional expertise with business knowledge to solve problems and makes good decisions for the overall business.
• Trains, develops, and manages an effective regulatory team via direct and indirect reporting structure.
• Builds partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
• Manages critical issues in collaboration with the NA region, taking leadership for the regulatory contribution especially when more than one region is impacted.
• Responsible for assisting with the development and implementation of regulatory processes.
• Recruits, develops, manages and mentors regulatory professionals and helps create a goal-oriented culture.

Required Education:

• Bachelor’s degree in a science related curriculum required, advanced degree preferred.

Qualifications:

• 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.
• Preferred candidates will have 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 and able to identify and proactively respond to emerging regulatory trends anticipatin