Regulatory Manager

hace 4 semanas

Castelló de la Plana, Castellón, España Precision Value & Health A tiempo completo

Regulatory Manager / Senior Regulatory Manager

Join to apply for the Regulatory Manager / Senior Regulatory Manager role at Precision Value & Health .

Job Type : Regular Full-time

Division : Precision for Medicine

Business Unit : Clinical Solutions

Requisition Number : 5415

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and guidance for clinical trials, agency meetings, orphan designations, pediatric planning, and accelerated procedures. The role involves preparing regulatory submissions, coordinating with authorities and ethics committees, and leading regulatory activities within project teams.

Essential functions include :

  • Providing regulatory guidance throughout the clinical development lifecycle
  • Preparing and reviewing submissions to regulatory authorities and ethics committees
  • Developing regulatory documents to ensure compliance
  • Representing Global Regulatory Affairs in project meetings
  • Leading and coordinating regulatory teams and activities
  • Maintaining project plans and regulatory intelligence tools
  • Contributing to regulatory strategy and timeline development
  • Staying updated on laws, regulations, and guidelines
  • Providing GCP guidance and training

Qualifications : Minimum Required :

  • Bachelor's degree in a scientific or healthcare discipline
  • 5+ years regulatory experience for Managers, 7+ for Senior Managers

Preferred :

  • Basic understanding of financial management

Other requirements :

  • Experience working for a CRO and leading clinical submissions
  • Knowledge of drug development, regulatory milestones, and regional regulations (EU, US)
  • Ability to interpret clinical study results and understand clinical trial methodology
  • Willingness to travel domestically and internationally
  • Strong interpersonal and team skills
  • Professionalism and punctuality
  • Ability to manage multiple tasks efficiently
  • Self-motivated and proactive
  • Effective communication skills in English

We offer a dynamic environment focused on groundbreaking cancer therapies, valuing employee contributions and fostering innovation.

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