Associate Manager, Regulatory Operations

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.

General Description:

The Associate Manager, Regulatory Project Manager, is responsible for providing regulatory project management support, to the growing BeiGene Portfolio. This person will be a part of the Global Regulatory Project Management Function at BeiGene and will support NDAs/BLAs, INDs/CTAs and other regional regulatory filings.
 

Essential Functions of the job:

• Partner with cross-functional team members to develop, gain approval and execute on the regulatory strategy/submission plan (specifically for the regulatory submissions in the RoW), and manage the associated timelines, deliverables and resources.

• Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from cross-functional team/key stakeholders, ensuring that regulatory timeline are aligned with corporate goals.

• Facilitate regulatory team and working group meetings (schedule, prepare / distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership and discussion facilitation experience required).

• Partner with key stakeholders to plan and track regulatory documents for submissions in line with ICH requirements, and other regional requirements and scientific and company policies and procedures.

• Facilitate the transparent and timely communication on the submission-related activities and ensure that all stakeholders are fully informed and stay current on the submission activities and their status.

• Proactively identify, resolve and escalate issues that may jeopardize project completion on time

• Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, and regulatory project management practices
   

Supervisory Responsibilities:  

• Direct Reports- N/A

• Indirect Reports- N/A
   

Core Qualifications:

• 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.

• Must be able to understand and communicate scientific and business elements associated with the therapeutic area(s) of assigned projects.

Computer Skills:   

• Moderately proficient with project management tools including Smartsheet, MS project and document management system.

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

Other Qualifications:   

• Bachelor’s or higher degree in a related field with 4+ years of experience in (bio)pharmaceutical industries, preferably in regulatory project management, (bio)pharmaceutical project management and/or related discipline. PMP or similar certification preferred.

• Working knowledge of drug development and regulatory agency regulation, guidelines, and submissions.

• Proficient with project management tools (Microsoft Project, Smartsheet, etc).

• Self-directed individual; works independently and collaboratively with direction in matrix organization.
   

Travel:  Minimal outside of the United States

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

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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.