Business Process Analyst-Regulatory

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

Business Process Analyst - Regulatory Affairs

Join us

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.

Objectives

• Data Analysis
  : Evaluate
  Regulatory 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.

Requirements

• 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.

Skills

• 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

Would be a plus

• Leadership experience from process improvement projects
• Experience with Veeva Vault RIM

We offer

• Extensive benefits package
  (cafeteria, stock program, private life insurance)
• Training and development
  opportunities
• Medical services (Medicover) and free in-house medical care are provided
• Various sports opportunities:
  gym, swimming pool, sauna, AYCM
• We support the work-life balance with
  multiple days home office per week and provide flexible working hours

The Richter community is looking forward to your application.