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Subject Matter Expert - Regulatory Intelligence

Aplica ya
Mapa de ubicación: Madrid, Spain Full time R1317817

Descripción del trabajo

We are looking for a passionate Subject Matter Expert for our Regulatory Intelligence area.

As the regulatory Subject Matter Expert, you will collaborate closely with a broad network of internal and external specialists working on active project delivery. You will also be leading the on-going creation and quality management of the future regulatory content. This role will involve actively interacting with customers to discuss

The IQVIA Regulatory Intelligence service provides the pharmaceutical and medical device industries easy access to original and translated regulatory documents, summarized regulatory intelligence and comparative tables with up-to-date key regulatory requirements worldwide.  As we look to develop our Regulatory offering further, this role is to be part of the team designing for the future of Regulatory Intelligence.

Principle Accountabilities:

To Accomplish this role, the candidate will have following responsibilities

  • Subject matter expert (SME) in Regulatory submissions

  • Proactively drive and successfully complete this future content development project by:

    • Monitoring new, revised or emerging regulatory requirements

    • Contributing to the content identification and requirements and the content creation as well as supporting the QC of the content prior to launch.  

    • Proactively engage with team members providing mentoring, coaching and sharing subject matter expertise to content editors

Experience and Skills Required:

  • Qualifications in life sciences or related discipline

  • Subject matter expert (SME) in Regulatory submissions eg

    • Chemistry, Manufacturing and Controls,

    • Variations

    • New product registrations

  • Possesses at least 5 years of relevant regulatory affairs experience and/or technical expertise preferably in consultancy, preparing application dossiers

  • Demonstrated ability to manage and drive project contributions in a timely manner

We invite you to join IQVIA™

  • Recognized by Great Place to Work as the second best company to work for in Spain (March 2019)

  • FORTUNE Magazine's World's Most Admired Companies list for the third year in a row (January 2020)

  • Recognized by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO)

  • Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year.

  • A site-nominated award recognizing contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity.

  • IQVIA™ named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.

IQVIA™ is an equal opportunity employer. We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other "protected status.“

If you're not a EU citizen you must have a resident visa or a permanent visa.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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