Join us in our exciting journey!!

We currently require a motivated and enthusiastic professional to join our team.

Under general supervision, you will be able to prepare and/or review regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients, as well as provides regulatory support for assigned projects.

Responsibilities:

• Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
• Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
• Carry out the activities required to guarantee the correct storage and distribution of medicines.
• Review the documentation of the lots and those placed on the market.
• Carry out the activities required for quality claims and temperature deviations, as well as for inquiries made about the quality of the products.
• Management of medications in special situations.
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
• Performs other tasks or assignments, as delegated by Regulatory management;
• Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;
• SIGRE management
• Prepare and update technical-sanitary documents related to:
  • Technical memory
  • Maintenance of laboratory authorizations.
  • Quality contracts corresponding to all GMP / GDP activities.
  • Management of foreign trade permits, certifications, etc.
  • Support documentation required by the authorities related to: quality incidents, shortages, suspicion of counterfeit drugs, etc.
  • Management for the maintenance of the certificates of Good Distribution Practices (BPD

Our ideal candidate: Skills & other requirements

• Bachelor's Degree Degree in Lifescience or related discipline Req Or
• Master's Degree Degree in Lifescience or related discipline Req
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Proficiency both in English (written and spoken) and Spanish

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.“

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career goals, we are here to ensure you get there!

Are you interested or do you know the ideal candidate?

• If you know the right candidate or for more information on this role please contact susana.cangas@iqvia.com or ana.rey@iqvia.com 
• Please note is necessary that your application is registered in our Talent Network to process your candidacy

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.