Regulatory Intelligence Specialist

hace 2 semanas

Barcelona, Barcelona, España Iqvia A tiempo completo

We are seeking a highly skilled Regulatory Intelligence Specialist to join our team at our Madrid Center of Excellence office. This position will provide broad support on monitoring and analyzing the changes and evolution of the local regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders for both drug and medical devices.

Key Responsibilities:
  • Assess regulatory intelligence information for relevance and impact to industry's internal processes, drug development projects and/or regulatory strategies to create and enrich the IQVIA proprietary documents.
  • Monitor agency and professional websites, local specialized press, conferences, and select documents to be integrated in line with the IQVIA scope, editorial and intelligence management processes.
  • Identify business critical aspects and communicate effectively to internal and external stakeholders. This includes regular updates on new information that could impact clinical trial execution, pharmacovigilance activities, manufacturing quality as well as other ad hoc requests.
  • Synthesize information from regulatory documentation as well as interaction with local country experts as needed.
  • Share/Input data into systems or tools to enable effective knowledge management of country-level operational intelligence data.
  • Develop and refine regulatory intelligence processes and procedures to build efficiencies.

Required Knowledge, Skills and Abilities:

  • Proficient in proofreading and editing in Indonesian and English.
  • Capability to work remotely with peers in an international environment.
  • Good understanding of the drug development and commercialization process.
  • Ability to research, analyze, and extrapolate critical regulatory information.
  • Highly organized and able to work independently to meet deliverables on time and on target.
  • Team-oriented and strong relationship builder, able to effectively collaborate with a range of individuals across the organization and externally.
  • Attentive to details and focused on quality output.
  • Effective communicator - both written and oral - in a multi-discipline team environment.
  • Proficient in the navigation of intelligence database(s).

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