Senior Manager / Associate Director, Regulatory Affairs, Japan

Job Description : About the Company :

BeiGene (NASDAQ : BGNE; HKEX : 06160; SHA : 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 8,000 colleagues across five continents.

GeneralDescription :

The Associate Director, Regulatory Affairs, Japan will be responsible for developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives, and in coordination with key internal stakeholders. This individual will manage regulatory aspects of compounds / biologics 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. Externally, the individual will interface with outside regulatory agencies and business partners regarding development, regulatory, and registration strategies in Japan. 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

• Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in Japan markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions in Japan.
• Uses extensive knowledge of Japan and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
• Responsible for the preparation and submission of documentation to support investigational and marketing registration packages in Japan and ensures timelines are met.
• Reviews sections of CTN, NDA, and other submission documents in support of clinical trials and marketing applications, and their amendments in Japan in conformance with Japan regulatory requirements.
• Liaises and negotiates with Japan 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 Japan and global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of Japan regulation.
• Integrates functional expertise with business knowledge to solve problems and makes good decisions for the overall business.
• Trains, develops, and manages direct reporting line.
• Manages critical issues, taking leadership for the regulatory contribution.
• 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.

Core Competencies, Knowledge and Skill Requirements

Communication & Interpersonal Skills

Qualification Required :

Computer Skills :

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

Other Qualifications :

Travel :

Ability to work on a computer for extended periods of time

What we offer to our valued employees :

Market competitive compensation package including performance-based annual bonus scheme

Company shares (generous welcome grant and performance-based annual equity plan!)

Full-time working from home

In-house and external learning and development opportunities

Fantastic benefits program as per the current policy including;

Health Insurance provided

Medical Check-up, flu vaccine reimbursement

Home-office setup allowance

Monthly reimbursement for home office expenses (i.e. internet, mobile..)

Wellness benefits (Employee Assistance Program)

Paid parental leave

Annual leave

Marriage leave and allowance, condolence leave and allowance

And more as the benefit programs keep improving!

Plus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear : Cancer has no borders and neither do we.

BeiGene is proud to be an Equal Opportunity Employer :