International Open Positions
With 530 years of heritage, more than 2,500 employees, a leading Research and Development Center and two major production sites in Prague and Bucharest, Zentiva strives to be the champion of Generics to support the daily healthcare needs of people living in Europe.The growth of our organization brings new opportunities for our people to fulfil their potential. It also positions us well to attract the best talent and retain our team to secure our success for future generations. Join us!
Regulatory Strategy & Planning Manager
• To define and update global regulatory strategy for the Zentiva projects, to act as Regulatory Work Package Leader in the projects/programs.
o To define and update global regulatory strategy for Zentiva projects/programs with respect to the project type/territorial perimeter/timelines to support launch in time.
o To set up registration risks/their probability and impact on a strategy defined, as well as their mitigation for an intended medicinal product with respect to an optimal market entry through Zentiva's perimeter.
o Monitoring and regular project/program reporting with respect of key milestones delivery.
o To cooperate with internal and external stakeholders to assure all relevant information and data allowing optimal project regulatory strategy and to communicate properly all regulatory relevant information (news, changes, risks etc).
o To track and analyse regulatory strategies and results for dedicated projects, evaluate and communicate lessons learned.
• To provide regulatory strategy support during the project
o To organize and ensure regulatory/scientific/legal advice/opinion for Zentiva portfolio.
o To communicate with Health Authorities/external experts.
• To participate in the product lifecycle with respect to its maintaining on the market
o with respect to new regulatory opportunities (territorial extensions, newly emerging markets etc.) and
o providing information on legislation trends and their impact on the already registered products with respect to protecting and maintaining the products.
• To provide relevant data for potential projects (market exclusivity, reference product, registration procedures, type of application, competitor’s data)
• To monitor and to define legal regulatory environment in countries intended for launching the Zentiva products
• University degree in Natural/Pharmaceutical/Medical Sciences
• At least 5-years of experience in Pharmaceutical industry or Health Authority
• Experience with Project Management
• Knowledge of regulatory environment
• Presentation, communication and organization skills are essential
• Advanced knowledge of English
• An opportunity to work for a successful international company
• An opportunity to broaden your knowledge and expertise in regulatory field
• Continuous language and personal development
• An attractive compensation & benefits package