Business Process Analyst-Regulatory

Join the professional team of the 120-year-old Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region!

New molecules, new medicines, new processes, and new technologies - Richter invites innovative minds to exploit their full capacities. With our research and development base with 1000 professionals, we have one of the most significant innovation centres not only in Hungary but in the entire Central and Eastern European region. In addition to applied scientific work, we also support individual research fields and topics, as well as publishing activities and participation in scientific life.

Gedeon Richter is looking for a committed and experienced professional for the position

Embrace data-driven insights to enhance pharmaceutical product evaluations and drive impactful outcomes. Join a team committed to continuous improvement and cutting-edge tools to optimize regulatory operations. Harness data complexity to support strategic decision-making and elevate the Global Regulatory Science organization. Strengthen our Center of Excellence by developing robust analysis competencies, empowering regulatory professionals to uncover trends and insights that shape future strategies.

Data Analysis: EvaluateRegulatory operational data (Regulatory costs, capacities, process KPIs) that provides actionable insights into our operational efficiency, help in making informed decisions. By analyzing data, the Business Process Lead can identify trends, patterns, and areas for improvement, leading to more effective regulatory planning strategies

Process Improvement: This role will focus on identifying inefficiencies in current processes and implementing improvements (Global Regulatory Affairs and Global Patient Safety). Streamlined processes will lead to faster regulatory approvals, reduced operational costs, and improved overall efficiency.

Risk Management: By proactively assessing and mitigating product data compliance risks, this role will help safeguard the organization against potential regulatory breaches and their financial and reputational impacts.

Stakeholder Coordination: The role will facilitate better communication and collaboration between different departments and directorates, ensuring that regulatory & safety data requirements are understood and integrated into business processes effectively.

Continuous Improvement: Establishing this role will promote a culture of continuous improvement within the Global Regulatory Science Directorate. Regular reviews and updates of processes will ensure that the organization remains agile and responsive to regulatory changes. This role will gain valuable insights for further process enhancements

Training and Development: The role will provide training and support to employees, enhancing their understanding of best practices for process excellence. This will lead to a more knowledgeable and compliant workforce.

Performance Monitoring: By tracking and analyzing key performance indicators (KPIs), this role will measure the effectiveness of process improvements and compliance initiatives, providing valuable insights for further enhancements.

Master's degree in Life Sciences, Business Administration, Process Management or related field

Formal certification on Lean Six Sigma, Certified Business Process Professional (CBPP) and/or AI in Business Process Management is a plus.

Data Analytics: Proficiency in data analysis tools and techniques to interpret complex regulatory data.

Data Presentation: Strong skills in creating clear, accurate, and engaging presentations of regulatory data.

Business acumen: Understanding of business operations and the ability to align regulatory strategies with business goals

Regulatory Affairs Knowledge: Understanding of global regulatory affairs processes from development to life-cycle management

Pharmacovigilance Expertise: Understanding of pharmacovigilance processes

Communication Skills: Excellent written and verbal communication skills to effectively interact with internal & external stakeholders

Analytical Skills: Ability to analyze and interpret complex regulatory and scientific data

Problem-Solving: Strong problem-solving skills to navigate regulatory challenges and develop innovative solutions

Digital Skills: Digital driven appetite and mindset are a must

Leadership experience from process improvement projects
Experience with Veeva Vault RIM

The Richter community is looking forward to your application.