Regulatory Affairs Business Analyst

Teva

Zagreb, Croatia

The opportunity

As part of the RIM team, you will develop and implement the RA business systems strategy to ensure Global Regulatory Affairs (GRA) systems meet evolving business needs. You will provide expert business analysis for the development of strategic system roadmaps and the successful implementation of projects required to deliver technology solutions supporting the GRA business. You will carry out Business Data Administration and Business System Ownership responsibilities. Partnering with industry stakeholders and health authorities, you will influence emerging requirements like ISO IDMP and FMD. Additionally, you will manage the Teva XEVMPD submissions for Article 57 compliance and support the Regulatory Data Administration team in maintaining data integrity and reliability for accurate reporting and decision-making.

How you’ll spend your day

Provide effective business project management for regional and global projects focused on improving regulatory data quality, provisioning regulatory data for internal re-use via system integration, or implementing any business or technology change that impacts regulatory data and documents or the regulatory technology landscape;
Lead cross-regional and cross-functional project teams, working and influencing staff at all levels within the organization to ensure regulatory systems and related processes are developed and enhanced to meet diverse regulatory business process and data requirements;
Work closely with the Mumbai-based RIM XEVMPD and GRO Regulatory Data Administration teams. Collaborate with GRA functional teams dependent upon these operations. Act as project leader, change manager, and/or escalation point for these operations to ensure their continued effectiveness and to ensure GRA business needs continue to be met by these operations;
Perform deep dives into current business processes and map future processes. Expertly interrogate regulatory legislative and guidance documents, drawing on that expertise to shape the to-be processes to ensure business compliance;
Provide effective Business Data Administration oversight for GRA data, including data management and data quality decisions impacting system dictionary controlled values. Define, obtain agreement to, and communicate GRA data process-related work instructions. Perform the role of Business System Owner for GRA systems.

Your experience and qualifications

Bachelor's Degree in Life Sciences;
Experience in the pharmaceutical industry with direct experience in Regulatory Affairs;
Knowledge of global regulatory requirements and industry regulatory standards;
Good understanding of regulatory business processes;
Experience analyzing the data requirements of RA business processes and managing regulatory data to maintain regulatory compliance and support growing RA business data demands;
Good knowledge of Veeva Vault suite is preferred, but not required;
Experience leading cross-functional project teams and change projects, including working within a multifunctional/geographical matrix;
Ability to work independently and handle complex project assignments;
Excellent verbal and written communication skills;
Ability to work with stakeholders at all organizational levels.

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