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Senior Regulatory Portfolio Manager

1 miesiąc temu

Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat
Company Overview

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together.

Job Description

We are seeking an ambitious Senior Regulatory Portfolio Manager to ensure the development of regulatory strategy(ies) and their execution for assigned assets consistent with the strategic activities for GSK's Classic & Established Product (CEP) portfolio. This goal must be achieved while ensuring compliance with both internal GSK process/policy and with appropriate regulatory requirements.

This role requires a strong understanding of European Regulatory landscape and procedural requirements, guidelines and working practices. Experience of all phases of the drug development process in regulatory affairs, with particular emphasis on maintenance and lifecycle management of marketed products, is essential.

The successful candidate will have a deep understanding of licensing requirements in other regions (APAC, LATAM, MENA) and experience with such Agencies. They will be able to develop product/therapeutic knowledge in new areas and work in a complex environment.

Required Skills and Qualifications
  • Experience of all phases of the drug development process in regulatory affairs
  • In-depth understanding and practical experience of European Regulatory landscape and procedural requirements, guidelines and working practices
  • Knowledge of licensing requirements in other regions (APAC, LATAM, MENA)
  • Ability to work in a complex environment
  • Good communication and influencing skills
Benefits

We offer a competitive salary of approximately $100,000 per year, an annual bonus based on company performance, healthcare and wellbeing programs, pension plan membership, and shares and savings program. We also provide a wide range of additional benefits including:

  • Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs)
  • Established job in an international, well-known biopharma company
  • Opportunity to work in professional team playing important role in introducing and GSK portfolio on the markets
  • Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)
  • Recognition awards for additional achievements
  • Supportive & friendly working environment with integration events
  • Possibilities of development within the role and company's structure with personalized learning approach (mentoring, coaching, online training platforms)
  • Extensive support of work life balance (flexible working solutions, health & wellbeing activities)
  • Modern office with creative rooms, fresh fruits every day
  • Free car and bike parking, locker rooms and showers.