Senior Director, Regulatory Affairs CMC

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne 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:
BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team based in US, partners with the counter-part based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and health authority interactions throughout the product lifecycle. The individual also leads the team to establish or/and optimize biologics regulatory CMC processes. The individual manages direct reports of 10+ and reports to global head of regulatory CMC.

Essential Functions of the job:
• Lead, develop, and optimize the current biologics regulatory CMC team in US.
• Lead or/and oversee the development and implementation of biologics regulatory CMC strategies as well as lead the team authoring and managing CTD CMC sections to ensure on-time and high-quality submissions for investigational, marketing, and post-approval applications.
• Lead or/and oversee the development and implementation of biologics regulatory CMC strategy and execution in the preparation of timely responses to HA CMC questions, pre-meeting packages, and interactions with Heath Authorities.
• Work collaboratively with cross-functional stakeholders and communicate biologics regulatory CMC overarching strategies for alignment,
• Lead or/and oversee biologics CMC change control regulatory CMC impact assessment and ensure right regulatory CMC actions are taken timely.
• Lead or/and oversee regulatory risk assessment, identify key biologics regulatory CMC issues and mitigation activities needed throughout product lifecycle. Escalate the critical issues to senior management timely.
• Lead or/and oversee the establishment or/and optimization of internal regulatory CMC SOP, working instructions, and best practice, etc.
• Ensure proper regulatory CMC assessment and actions are taken when recalls or product complaints arise during product lifecycle.
• Review and approve regulatory CMC submission documents, SOPs/WIs, etc. in regulatory information system (RIM).
• Oversee or lead the assessment regulatory CMC aspects for due diligence projects.
• Lead or participate in external activities/conferences representing the company or the department when needed.
Supervisory Responsibilities:
Manage existing US based biologics regulatory CMC team of 10+ members.

Computer Skills:
Microsoft 360

Other Qualifications:
• Minimum 15 years of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development, manufacturing, Quality, etc. including minimum 8 years of regulatory CMC experience with a Bachelor's Degree required.
• A proven record of leading Health Authority interactions, CTA, BLA/ submission, and subsequent response to HA queries.
• Demonstrated leadership of managing a team of 10+ people in global working environment is a must-have.
• Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (upstream, downstream, formulation, analytical, manufacturing, QC, QA, etc.).
• Experience in gene/cell therapy or/and medical device is a plus.
• In-depth knowledge of ICH requirements, global regulatory CMC requirements; Knowledge/experience in Quality Assurance and GMP regulation is a plus.
• Experience in authoring complex technical documents, CTD M2 and M3 sections, and their lifecycle management.
• Excellent oral and written communications skills are a must-have. Multilingual is a plus.
• Excellent interpersonal, communication, and problem-solving skills.
• Strong ability to effectively lead and influence in the collaborative and fast-moving work environment.
• Experience of using Veeva Vault system is a plus.

Travel:
As needed

Global Competencies

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

• Fosters Teamwork
• Provides and Solicits Honest