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Nabídka volných pracovních míst

Regulatory Strategy & Planning Manager

Your responsibilities:

• 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

We require:

• 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

We offer:

• 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


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