Job Description

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.

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About the Company:

• BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 9,500 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.
• 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 Senior Director, Head of Regulatory Affairs, Asia Pacific will be responsible for developing, implementing, and advising on APAC regulatory strategies for development programs to secure and maintain market access for product(s) in Asia Pacific region 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 lifecycle of the product.
• This role will directly manage a team of regulatory affairs professionals across a range of levels and assets and must be equally adept at providing technical as well as professional growth and leadership to the team.
• The position could be in major countries Beigene has presence.

Essential Functions of the job:

• Build and lead the Asia Pacific regulatory team across various locations in the region.
• Supervise team members and external vendors to the Regulatory Affairs function and provide management and guidance across the function.
• Manage the Asia Pacific regulatory team activities, budget and staff including identifying, hiring and training additional staff as needed.
• Represent Asia Pacific RA team within the BeiGene Global Regulatory Leadership. Work in close collaboration with BeiGene Global functions to integrate all aspects of Asia Pacific and APAC regulatory strategy.
• Drive Regional Regulatory Affairs strategy and execution for the organization across key focus areas in hematology and solid tumours.
• Ensure that the interactions between Regulatory and other functions in the Asia Pacific region are managed optimally. Work in close collaboration with Asia Pacific functional heads to integrate regulatory within clinical development, commercial, medical and market access etc initiatives and strategies.
• Oversees regulatory aspects of submissions and communications with the respective Health Agencies by departmental staff. Manage timelines and resources to achieve stated objectives, ensuring tracking tools and regulatory databases are maintained up to date.
• Oversees strategic placements of key Asia Pacific countries in global clinical development plans.
• Provide strategic regulatory support to internal brand, product and project teams. Pro-actively communicate the latest regulations, guidance, and actions from Asia Pacific countries and competitors that may influence the landscape and assesses the potential impact on regulatory and/or business strategy and planning.
• Contributes to the development and implementation of processes and procedures relevant to the operations of the regulatory function and its interactions with internal stakeholders.
• Oversee all operational aspects of regulatory submissions, including maintaining timelines and developing and coordinating submission content for various regulatory agency applications, safety, amendments, and IND safety and annual reports.
• Represents BeiGene in industry associations relevant to the Asia Pacific region.

Supervisory Responsibilities:

• Manage a team of RA strategists in the region.

Qualification Required:
Qualifications:

• A minimum of 12 years in the biotechnology or pharmaceutical industry and a minimum 8 years in a Regulatory leadership capacity with a broad background in oncology.
• Knowledge of Inflammation and Immunology a plus. Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, prior experience with both small molecules and biologics
• Experience leading multiple HA interactions leading to Agency approval actions.
• Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across multiple functional areas.

Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone\'s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability \xe2\x80\x93 Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.

Computer Skills: Microsoft Words, Excel, PowerPoint

Other Qualifications: Veeva regulatory publishing

Travel: Expectation of occasional travel

Education Required: Bachelor\xe2\x80\x99s degree in life sciences, with an advanced degree of MSc or PhD preferred

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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