Global Regulatory Lead Gx
Genzyme
Praha
před 5 dny

Lead a portfolio of products by actively contributing to the development and implementation of regulatory strategies and timelines

  • Lead and / or represent GRA on Global Regulatory Teams and / or GBU project teams
  • Interact with a cross-functional team in the collection, review and assembling of the scientific, clinical, manufacturing and administrative section documents for global submissions to regulatory authorities
  • Ensure the appropriate peer review of key regulatory documents and submissions across programs in the portfolio
  • Ensure registration plan preparation for Global Gx dossiers in cooperation with all relevant stakeholders in line with business needs, regular up -
  • date of respective tracking systems

  • Represent the assigned product towards Senior GRA Management and other governance bodies (i.e., sub-Safety Management Committee (SMC), Benefit Risk Advisory Committee (BRAC), etc.)
  • Proactively identifies and communicates to higher management all potential risks and options for issue resolution (e.g.
  • maintenance issues, submissions, etc.)

  • Research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
  • Recommends improvements to operating policies / processes
  • Ensure compliance with all internal and external requirements and procedures
  • Maintain professional working relationships with colleagues, fostering collaboration and idea sharing.
  • Education

  • Bachelor's degree and at least 3 years in Regulatory Affairs or relevant industry experience
  • Master’s, PharmD, PhD degree and 1-2 years in Regulatory Affairs or relevant industry experience
  • Education area of study in a scientific discipline / MS or Doctoral degree / Pharm D a plus.
  • Experience / Professional Requirement

  • Experience in Emerging Markets
  • Broad understanding of global pharmaceutical development path (market trends and competitive environment)
  • Broader understanding of CMC & clinical functions
  • Experience in a Global regulatory team preferable
  • Demonstrated ability to prioritize multiple projects
  • Strong multicultural awareness is a must
  • Excellent communication and organizational skills as well as attention to detail
  • Ability to work in a matrix team environment with strong interpersonal skills (collaborative, tactful and diplomatic)
  • Motivated, self-starter, and ability to work independently with minimal supervision
  • Proficient in MS : Word, Excel, Powerpoint and Project
  • Sense of urgency and perseverance to achieve results and deadlines
  • Knowledge / experience with Manufacturing, QA / QC and / or clinical development experience also a plus
  • Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.

    We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-

    term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

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