"Alerted.org

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

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.