General Description:

The Director, Regulatory Project Manager, is responsible for providing regulatory project management support to the growing BeiGene Portfolio. This person will be a part of the Regulatory Project Management Function at BeiGene and will lead global regulatory development and marketing applications.

Essential Functions of the job:

• Collaborate with key submission stakeholders to plan complex/major regulatory submissions for China, US, EU, Japan and the rest of the world (ie developing a global submissions filing strategy).

• Identify and propose improvement projects that harmonize RA ways of working across the regions and establish an educational platform to promote these initiatives.

• Key member of the Regulatory Project Management team. Contribute to working alongside the China & US team to identify, propose, develop and manage improvement projects.

• Direct submission communications and ensures that all submission customers are fully informed and knowledgeable of submission activities and deliverable status.

• Lead the cross functional filing team, who are responsible for the content of the dossier, to ensure quality Regulatory submissions are made on time.

• Liaise with other project managers on the team as well as regulatory clinical/operations team members in order to meet the business need and timely delivery of submissions.

• Organize and manage cross functional meetings to coordinate, plan, and track submissions for Regulatory.

• Responsible for ensuring clarity when preparing meeting minutes.

• Responsible for the planning, tracking and project management of complex regulatory submissions in line with ICH requirements, China requirements, other regional requirements and scientific and company policies and procedures.

• Responsible for maintaining global submission timelines.

• Manage and mentor more junior members of staff on how to create project plans and develop projects.

• Strategic thinking is required, with a focus on process improvement and optimization.

• Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.

• Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.

• Accountable for their work; shows initiative and leadership, displaying integrity in everything they do, thriving in a team environment, and seeks excellence as the measure of success.

• Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure.

• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.

• Manages critical issues, taking leadership for the regulatory contribution

• Responsible for assisting with the development and implementation of regulatory processes as directed.

Experience

• MUST have 10+ years of pharmaceutical development and regulatory global submissions experience with a Bachelor’s Degree, or 7+ with a Master’s.

• Experience should include 7-10 years of participation in cross-functional project management activities.

• MUST have prior experience with both small molecule and biologics a must.

• MUST have managed multiple Marketing Applications and/or LCM submissions at the same time and in multiple regions from submission filing to approval.

• Experience in leading a team of cross-functional individuals across regions.

• Experience in managing shifts in competing priorities or unforeseen challenges, without compromising quality, attention to detail and timeline deliverables while successfully communicating and working with line management, team members and customers.

• Experience in working well independently and in a group environment.

• Demonstrated progressively responsible duties in prior positions.

• MUST be familiar with the following regions for filing submission: Asia Pacific, Europe, United Kingdom, Switzerland, Russia, South America, Middle East, China, United States.

Supervisory Responsibilities:

• Direct Reports- None at this time.

• Indirect Reports- None at this time.

Computer Skills:

• Proficiency with project management and document management tools including Smartsheets, MSProject, OnePager, PowerPoint, Prezent

• Proficiency with PC utilizing the MS Office suite of applications.

• Veeva BRIM and Power BI experience a plus.

Other Qualifications:

• PMP or similar certification preferred.

• RAC certification a plus.

• Working knowledge with common project management systems required.

• Minimum of 7 years of prior job experience preferred in a pharmaceutical project management role, working with multi-department/multi-functional teams

• Ability to multi-task and determine appropriate priorities if conflicts arise.

• Great communicator and negotiator to solve conflict resolution.

Travel: < 20%

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.