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    Regulatory Affairs Professional - Alcobendas, España - Parexel

    Parexel
    Parexel Alcobendas, España

    hace 5 días

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    De jornada completa
    Descripción

    When our values align, there's no limit to what we can achieve.

    Parexel is seeking highly motivated and experienced individuals for the position a Senior Regulatory Affairs Associate. This role can be home, or office based in various locations in Europe. As part of our team, you will have the opportunity to work within a collaborative environment and deliver services within your technical expertise. Join us and make a difference in clinical research

    Main Role Responsibilities:

  • Demonstrate the ability to prioritize work and define steps needed to achieve project outcomes.
  • Liaise closely with more senior colleagues to discuss issues and resolve conflicts.
  • Provide suggestions for improving project efficiencies and results to the project technical lead.
  • Seek out information from previous projects, other client work, or colleagues to complete assigned project activities.
  • Produce quality work that meets the expectations of the project Team Lead and the client.
  • Serve as a Regulatory Lead for small scale projects or work streams.
  • Ensure accurate project reporting is in place as the main client contact.
  • Ensure project team compliance and adherence to project scope and objectives.
  • Identify new opportunities through Change In Scope or add-on businesses from existing work.
  • Ensure timely project close-out activities are completed.
  • Follow and implement the organization's consulting models and methodologies.
  • Provide technical and/or business consulting services within your personal area of expertise.

    • Requirements:

  • Previous experience working in industry in support of Global Labeling, Regulatory (Clinical/Safety), or Medical Writing for labeling updates.
  • Understanding of the Regulatory processes required to update labeling of a product.
  • Familiarity with the Company Core Datasheet (CCDS), and its implementation into labeling and artworks.
  • Understanding of Safety Signal Management and the impact of confirmed safety signals on labeling.
  • Understanding of Periodic Safety Update Reports (PSUR) and potential impact on labeling.
  • Knowledge of the relationship between labeling and artwork processes.
  • Familiarity with the Addendum to Clinical Overview (Module 2.5) and its preparation to support a labeling variation.
  • Knowledge of Regulatory requirements for labeling updates in different regions (EU, US, and APAC).
  • Understanding of EU readability and PIL (Patient Information Leaflet) testing.

    • Skills and Qualifications:

  • University degree in a scientific field
  • Strong organizational and time management skills.
  • Excellent communication and oral skills, with the ability to work efficiently as part of a team.
  • Strong interpersonal skills.
  • Proactive and efficient work ethic.
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