BeiGene is a global biopharmaceutical company dedicated to the discovery and development of innovative drug therapies for the treatment of cancer.

　　This role will support global labeling projects and programs connected to labeling process effectiveness, efficiency and compliance, including external collaboration initiatives (SDEA labeling compliance) and internal alignment across the broader organization. This role will support the development, planning, coordination, implementation, and tracking of various labeling deliverables and ongoing initiatives within the Regulatory Affairs Labeling Group.

　　It requires close cross-functional collaboration, analysis and understanding of interdependencies to support a range of project planning/management and infrastructure/process activities.

　　Growth opportunity to expand to management of labeling documents such as CCDS, US and Canadian labeling.

　　Essential Functions of the job:

　　Drives cross-functional working groups to identify, assess, design and/or implement improvement opportunities to measure and reduce compliance risk and increase efficiency of the end-to-end Labeling process. Process-oriented with familiarity of GMP requirements and working in a highly regulated industry. Good understanding of GxP/GMP applications. Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information.

　　Assists with development, revision and maintenance of departmental SOPs, WIs and non-governance documents. Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.

　　Prepares necessary training and communication to relevant stakeholders to ensure the proper process execution.

　　Coordinates the timely availability of metrics and KPIs to demonstrate labeling process compliance and efficiency.

　　Records quality events for regulatory labeling team and monitors assigned CAPAs until issue resolution and closure. This includes the provision of guidance to labeling team to reduce instances of recurrence.

　　Serves as strategic regulatory partner and a liaison between the Global Labeling Business Users of the Systems to IT for new or enhanced technical solutions. Experience in systems (e.g., document management systems, labeling systems, etc...) to meet regulatory requirements is a must.

　　Serves as global regulatory labeling representative in company initiatives, as assigned by management.

　　Identifies industry trends and evaluates impact on BeiGene labeling policies and practices. Supports development of project strategies within teams and the department.

　　On an ad-hoc basis, supports the preparation of labeling deliverables, for submission to Health Authorities, implementation on market, inspection or audit.

　　Communicates with and provides services to a wide range of internal and external contacts. Anticipates and resolves problems, updates supervisor on status of projects.

　　Education Required:

　　Bachelor’s degree in project management, life sciences, or other related area, Advanced degree preferred.Qualifications Required:

　　BS degree with with 5 plus years of overall experience, with at least 3 years of applicable experience in biotechnology or pharmaceutical industry.

　　Prior regulatory labeling experience preferred.

　　Effective communication skills (verbal and written).

　　Ability to work cooperatively with others and provides significant contributions as a member of a team in addition to serving in a leadership capacity.

　　Strong organizational skills. The ability to be flexible and handle multiple tasks well, under pressure while demonstrating strong attention to detail.

　　Proficiency in MS Office and Project Management tools is mandatory.

　　Core Competencies, Knowledge & Skill Requirements:

　　Analytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives.

　　Strong planning, organizing, and execution skills.

　　Ability to proactively manage workload and meet deadlines.

　　Ability to provide and apply creative solutions to maintain workflow.

　　Ability to work collaboratively within a global team setting, and with staff of different backgrounds and experience levels.

　　Logical problem-solving skills, looks beyond immediate problems to consider root causes and addresses them.

　　Excellent verbal and written skills with great attention to detail

　　Possess a high degree of personal responsibility.

　　Communication & Interpersonal Skills:

　　Fosters open communication. Listens and facilitates discussion.

　　Strong negotiating skills and ability to think creatively and develop creative solutions

　　Proven ability to build trust and respect within the organization.

　　Ability to prioritize and handle multiple projects simultaneously.

　　Interacts with internal stakeholders and cross-functional team members, as required.

　　Supervisory Responsibilities:

　　NoComputer Skills:

　　Ability to work in a strong technical environment, MS office Suite, knowledge of Project Management tools, Labeling implementation and tracking systems, Document Management Systems, Packaging and Artwork Management Systems, Veeva Vault, Change Management Systems, SharePoint and other technical applications used in the regulatory environment.Travel:

　　Infrequent; national travel for team meetings and conferences, infrequent international travel.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.