Regulatory Affairs Business Analyst

2 months ago

Zagreb, Croatia Teva Pharmaceuticals Full time
Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

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
Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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