Join us in our exciting journey!!

We currently require a motivated and enthusiastic professional to join our team as a Regulatoy Affairs Officer (Regulatory focused).

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.

The role: Responsibilities

• Act 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.
• Carry out communications and telematic shipments to the AEMPS (LABOFAR), CCAA and professional groups (COF).
• 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.
• 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
• At least  2 years relevant experience
• 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;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
• Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

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 fourth year in a row (January 2021)
• 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 please share this job opportunity - for more information on this role please contact marta.saiz@iqvia.com
• Please note is necessary that your application is registered in our Talent Network (IQVIA website) 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.