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 incumbent will:

Lead the activities of the Global Regulatory Affairs SOP Committee regarding life-cycle management of Global Regulatory Affairs SOP compliance. To include but not limited to:

Chair the SOP Review Committee to ensure requirements are followed per applicable work instruction.

Assist GRA personnel through the Document Change Process

Guide external personnel to Global Regulatory Affairs to comply with SOP Review Committee requirements

Schedule and conduct adjudication meetings for issue resolution

Manage all applicable trackers/spreadsheets associated with the Global Regulatory Affairs SOP Committee.

Distribute SOP committee monthly reports.
 

Function as the chair of the Inspection Readiness Team. Leading the team to achieve the following goals (to include but not limited to):

To function as the GRA single point of contact for all notifications of internal audits and Health Authority (HA) Inspections impacting Global Regulatory Affairs (GRA).

To identify and mitigate process gaps that could potentially be considered compliance risks.

To assess GRA CAPAs to determine if the impact of the corrective actions pose a future compliance risk to other regions/functional areas of GRA.
 

Assist with the planning and coordination of training curricula for the Global Regulatory Affairs team.

Generate Change Management Form for Curricula Owner

Coordinate the modifications with Quality Training

Monitor delinquent training and assist personnel to achieve compliance

Guide managers in assigning their personnel the adequate parameters for on-boarding

Own and ensure the R Reg Affairs Global Reg Process & Compliance curriculum is updated and accurate.
 

Continuous Monitoring and Reporting

Establish metrics and KPIs to monitor the effectiveness of compliance monitoring and quality management activities.

Collaborate with Quality System record owners to promptly resolve overdue and/or nearly overdue records related to KPI reports.

Consistently provide senior management with reports on the progress of quality initiatives.
 

Support the global compliance team’s activities as assigned to include serving as liaison to BeiGene compliance activities external to GRA (to include but not limited to):

Information Governance (IG) Team

Clinical Operations Emergency Response Team

Global Standards Committee

Act as the GRA Point of Contact for Quality Initiatives to include but not limited to Quality Training and Quality Document Management Activities. Partner cross functionally with Quality to disseminate Quality Training as reviewed in Quality informational meetings.
 

Partner with Internal Audit Group to Conduct Gap Analysis

Post audit/inspection support in response to action items generated from the activity.

Assist in procurement of GRA Product Liability Insurance Responses.

Perform other duties as assigned.

Essential Functions of the job:

Independently lead/participate in GxP compliance activities (internal/corporate, CMO or supplier, CRO) and identify regulatory compliance gaps or risks.

Assess, manage training curricula in response to CAPAs/audits and assess corrective measures for internal and external GxP Compliance audits.

Work with Global Quality Compliance and Regulatory teams to ensure accuracy of compliance data across BeiGene network sites.

Perform duties as assigned to ensure compliance to global and local regulations.
 

Supervisory Responsibilities:

Team to be established including direct reports.
 

Computer Skills:

Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint), MS SharePoint.

Experience/Education Required:

Bachelor of Science degree, in a related scientific discipline or relevant professional certification. Requires a minimum of 8+ years’ experience in pharmaceutical, biologics, or biotechnology industry, with 5+ years of experience as a Regulatory Affairs compliance lead.

Other Qualifications:

Spoken/Written fluency in English required.

Strong project management skill set.
 

Travel: Must be able to travel approximately 25%, including international trips.

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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $142,600.00 - $192,600.00 annually

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.