Manager To Senior Manager, Regulatory CMC

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.
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 10,000 colleagues across five continents.
General Description
BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions to meet the aggressive timelines. The individual will provide support to cross-functional teams on CMC regulatory strategies.
Essential Functions Of The Job

• Develop and implement small molecule/large molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions for investigational, market, and post-approval applications.
• Prepare CTD M2.3 in Japanese based on M3 from Global RA CMC team.
• Prepare CTD M1.2 “Application Form” in Japanese based on M3 from Global RA CMC team.
• Respond/prepare answer against inquiry from PMDA with Global RA CMC
• Evaluate CMC “Change Control” on Japan filing impact and guide/evaluate judge “PCA” or “MCN” with global RA CMC team.
• Together with global RA CMC team, develop Japan regulatory strategy and execute in the preparation of timely responses to small molecule/large molecule CMC regulatory questions, pre-meeting packages, and interactions with Japan Heath Authorities as needed for the assigned project.
• Work collaboratively with cross-functional leads and communicates Japan CMC regulatory strategies for the assigned projects.
• Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle for Japan related submissions. Escalate the critical issues to senior management timely.
• Lead or contribute to development of internal small molecule/large molecule CMC regulatory guidance and working instructions for Japan submissions.
• Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project in the Japan market.
• Provide CMC regulatory review for clinical protocols and investigator brochures, etc., for the assigned project related to Japan submissions.
• Provide comments on new global guidance through company’s commenting process.
  

Supervisory Responsibilities
The position may have opportunity to manage direct report.
Qualification Required
Computer Skills:
Microsoft 365, Word, Excel, Power Point, familiar with Veeva vault is a plus.
Other Qualifications

• 3+ years of related pharmaceutical or pharmaceutical industry regulatory CMC experience with proven
• record of experience in global submissions for clinical trial/market applications and subsequent response to HA queries.
• Experiences to prepare CTD M2.3 and M1.2 (Application Form).
• Experiences to respond against inquiries from PMDA.
• In-depth knowledge of ICH requirements, US/EU/JP regulatory and requirements.
• Knowledge/experience with rest of world regions and GMP regulation and post-approval submissions is a plus.
• Experience in authoring complex technical documents and regulatory CTD (M2 and M3) sections.
• Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc).
• Excellent oral and written communications skills are a must-have.
• The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment
  

Travel
As needed
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
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.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity