Regulatory Team Leader
6 days ago
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
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