General Description:

The Associate Manager (AM), Regulatory Information Management (RIM) will serve as the global knowledge-center for the Regulatory Information Management System (RIM) Data Quality & Reporting. The AM will partner with key RIM data owners, RegTech, & RIM leadership in executing the RIM strategy to maintain the BeiGene RIM system as the authoritative source for regulatory data. The AM will ensure compliance with all operational data quality processes and data remediation activities related to RIM globally. The AM, RIM, will assist in maintaining and monitoring end-to-end (E2E) Regulatory data/information (integration, optimization, input, curation, quality, governance, and standards, and be responsible for analysis and reporting. As well, the AM may provide input for business process re-engineering to ensure stakeholder/partner, process, and system alignment in compliance with evolving electronic data standards. This role which reporting to the Senior Manager RIMT is a critical member of the RIM Data Quality team within RIM, contributing to the vision, mission, strategy and infrastructure of the Global Regulatory Operations department.

Essential Functions of the job:

Accountable and responsible for building and maintaining relationships with Regulatory and functional groups within and outside of the department including RegTech, business partners (e.g. CMC, Labeling SMEs) to ensure effective communication and efficient data monitoring as outlined below:

• Execute data quality reports at a defined cadence and work with data owners to resolve discrepancies.

• Manage data quality reports including minor and major updates.

• Provide ad hoc report outputs related to data quality, remediation, or governance.

• Maintain an effective relationship with all data owners globally to enhance BRIM adoption and BRIM process adherence.

• Contribute to the creation and management of E2E Regulatory data/information within the system(s). Provides oversight for data completeness, curation, quality, standards, reporting and analysis.

• Support the implementation and management of a comprehensive data model, master data, and ongoing maintenance or improvement in compliance with emerging health authority requirements or electronic standards.

• Ensure data availability in a complete, accurate, and timely manner through use of data quality monitoring methods for systems from planning of regulatory activities through Health authority interaction and to country/ regional implementation.

• Provide oversight for ongoing information management of submission records and associated global product registration records.

• Collaborate with business functions to articulate business needs for enhancements or new solutions within RIM, and alignment of business processes (e.g., needs for new markets and registrations).

• Assist in managing comprehensive global change request for RIM (data model and functionality) when related to data quality/remediation initiatives.

Requirements:

Computer Skills:

• Proficient with Microsoft Office applications (e.g. Word, PowerPoint, Excel, OneNote) & Adobe Acrobat

• Regulatory information management systems (e.g. Veeva Vault)

• Collaboration Tools (SharePoint, Smartsheet etc.)

Other Qualifications:

• 4+ years in the bio-pharmaceutical industry with prior Regulatory Operations and Information Management experience required.Bachelor's Degree a must. Master’s Degree in Information Sciences and/or Management desirable

• Working knowledge of regulations, processes and industry standards that govern regulated systems, records retention, and computer validation quality assurance for the management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance.

• Working knowledge of drug development and submission process.

• Excellent written, verbal, and interpersonal communication skills; able to communicate effectively cross-functionally.

• Able to work in a fast-paced environment and effectively manage workload and deliverables under pressure.

• Experience in managing day-to-day administration of regulated systems.

Travel: <5%

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.