Director, Global Regulatory Lead

General Description:

• The Director, Global Regulatory 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 the global project teams to plan, evaluate and recommend regulatory strategy. Externally, the individual will interface with business partners regarding global development, regulatory, and registration strategies.

• This role will support programs within BeOne's Development portfolio for Breast Cancer or BeOne's Hematology Franchise, with a focus on our BTK CDAC and BCL2 assets in development, a global regulatory remit.

Responsibilities:

• Provides high level global strategic and operational regulatory direction and leadership on projects including, but not limited to general 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.

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

• Supports the preparation and submission of global regulatory documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met including the review 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 decisions for the overall business.

• Manages and leads an effective global regulatory project team via 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, taking leadership for the regulatory contribution.

• Responsible for assisting with the development and implementation of regulatory processes.

• Mentors regulatory professionals and helps create a goal oriented culture.

Qualifications:

• BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry, and 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge and substantial working experience.

• Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics. Has sufficient regulatory knowledge to integrate inputs from other countries/regions to develop a global strategy and can develop and lead execution of holistic regulatory strategy while considering risk/opportunity, timeline, resource.

• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions about cross-functional topics to influence overall development strategy and to assess regulatory implications and develop regulatory strategy.

• Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading cross-functional regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.

• 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 strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.

• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Communication & Interpersonal Skills:

• Excellent interpersonal, oral and written communication skills. Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.

• Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.

• Strong negotiating skills and ability to think creatively and develop innovative solutions.

• Proven ability to build trust and respect within the organization.

• Ability to prioritize and handle multiple projects simultaneously.

• Interacts with BeOne employees and senior management.

• Interacts with external business partners and Regulatory Agencies.

Computer Skills :

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

• Ability to work on a computer for extended periods of time

Travel:

• Must be willing to travel approximately 10-20%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.