Regulatory Team Lead

3 days ago

Budapest, Budapest, Hungary Cognizant Full time €80,000 - €120,000 per year

Regulatory Team Leader

The position exists to participate in the regulatory program of our pharmaceutical partner, being part of a global team and leading a team which is part of it.

Job Location

Budapest, Hungary 9th District – Mill Park Office Building

Working Hours

40 hours per week

Normal business hours

Office attendance: Once a week

Offer

  • Competitive salary and cafeteria benefits; All You Can Move SportPass (at a discounted price), annual bonus, medical benefits, and other perks
  • Risk and accident insurance
  • Chance to be part of a rapidly expanding organization
  • Training and continuous learning and certification opportunities
  • Multilingual environment, native colleagues
  • Pleasant and inspiring working atmosphere with multicultural community and state-of-the-art technologies
  • Easy-to-access location and modern office building (easy to reach from city center, 10–15 minute commute)
  • Reimbursable language courses

Requirements

  • Education: Bachelor's degree in Life Sciences or Pharmacy

Experience:

  • 2–5 years of professional experience in Regulatory Affairs
  • Hands-on experience in Pharmacovigilance (PV) data handling

Skills:

  • Strong attention to detail and accuracy in documentation
  • Good understanding of regulatory guidelines and compliance standards
  • Proficiency in data management tools and MS Office applications
  • Language:
    Excellent written and spoken English (additional languages are a plus)

Tasks and Responsibilities

  • Tracking different regulatory submissions in the corporate regulatory database – update database with specific documents and/or information
  • Running daily queries, providing reports to client stakeholders
  • Applying technical knowledge to perform quality check on the entries
  • Ensuring compliance with KPIs
  • Optimizing utilization and effective resource allocation planning for the team
  • 100% compliance for work allocation
  • Good team management (indicated through no major escalations)
  • Ensure adherence to Cognizant and Client SOPs (Standard Operating Procedure) or internal standards and processes
  • Responsible for regular FMEA update and CAPA management
  • Managing BCP and operations
  • Effective risk management and issue handling by conducting daily huddle and escalating them on time
  • Communicating with client representative, understanding client expectations
  • Establishing and developing processes and procedures in the team
  • Complete all mandatory training courses as applicable
  • Communicating issues to Delivery Site Lead

The Cognizant community:

We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.

  • Cognizant is a global community with more than 300,000 associates around the world.
  • We don't just dream of a better way – we make it happen.
  • We take care of our people, clients, company, communities and climate by doing what's right.
  • We foster an innovative environment where you can build the career path that's right for you.

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