Executive Director, Global Regulatory Portfolio 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.

General Description:

The Executive Director, Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory strategies for development 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 regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met while leveraging expedited pathways where appropriate.

The individual has regulatory affairs departmental and cross-functional influence and acts as an advisor/liaison to senior management and project teams to plan, evaluate and recommend regulatory strategy. Externally, the individual will develop the global strategy for interaction with Health Authorities and will interface 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.

Essential Functions of the job:

Responsibilities

• Uses extensive knowledge of global regulatory environment and the ability to apply knowledge both strategically and operationally to development portfolio and projects, and marketed product regulatory issues to support corporate goals.

• Provides high level strategic and operational regulatory direction and leadership on projects including, but not limited to, global regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.

• Oversees the preparation of global regulatory documentation and ensures timelines are met, including the review of global submission documents in support of clinical trials and marketing applications, and their amendments to support investigational and marketing registration packages throughout the world.

• Supports regional team to negotiate with global regulatory authorities 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 global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation.

• Integrates functional expertise with business knowledge to solve problems and makes good …