Senior Regulatory Submissions Project Manager

hace 6 días


Madrid, Madrid, España IQVIA A tiempo completo

At IQVIA, we are seeking an experienced Senior Regulatory Submissions Project Manager to join our team. This is a fantastic opportunity for a skilled project manager to lead and manage high-profile Regulatory Submissions translation and localization projects.

About the Role

This challenging role requires a seasoned project manager with expertise in managing multiple projects simultaneously, from receipt to completion, while ensuring that IQVIA's standards are consistently met.

Key Responsibilities:
  • Lead and manage multiple Regulatory Submissions translation and localization projects at any one time, assessing project scope and selecting appropriate vendors to negotiate deadlines effectively.
  • Liaise with clients to assess and agree project parameters and requirements, ensuring effective communication throughout the project lifecycle.
  • Maintain excellent relationships with freelance and in-house linguists globally, monitoring and managing project status to anticipate and prevent issues.
  • Accurately complete project finances, including quoting and budgeting, and prepare and maintain project documentation and information.
  • Understand and adhere to IQVIA's Quality Management System, complying with relevant procedures and SOPs, and assist in the maintenance of linguistic assets, including glossaries and style guides.
  • Ensure high-quality outcomes through QA checks, providing weekend coverage as required due to project schedules.
Requirements:
  • A minimum of 2 years of experience working in Project Management within the Language Services industry.
  • A minimum of 1 year of experience working in Regulatory Submissions Project Management within the Language Services industry.
  • Bachelor's degree, ideally in a linguistic, business, or scientific field.
  • Fluency in English is essential, with an additional language being advantageous.
  • Excellent written/verbal communication skills and attention to detail to ensure high-quality standards are maintained.
  • The ability to meet strict deadlines, manage competing priorities, and change demands, along with advanced IT skills and experience working with TMS and CAT tools.
About IQVIA

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Our mission is to push the boundaries of human science and data science to create a healthier world.



  • Madrid, Madrid, España IQVIA A tiempo completo

    Regulatory Submissions Leadership OpportunityThe Associate Director – Regulatory Submissions is responsible for leading a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is in charge of developing and harmonizing the Regulatory Submissions Process.Key responsibilities include:Leading Regulatory submission Team Leaders...


  • Madrid, Madrid, España IQVIA A tiempo completo

    Regulatory Submissions Project ManagerThe ideal candidate will lead a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is responsible for the development and harmonization of the Regulatory Submissions Process. The successful candidate will have experience working with QRDs, CTDs, SmPC, PIL, and other regulatory materials...


  • Madrid, Madrid, España IQVIA A tiempo completo

    Regulatory Submissions Project ManagerAt IQVIA, we are seeking a highly skilled Regulatory Submissions Project Manager to join our team. As a key member of our Project Management team, you will be responsible for coordinating and managing the full lifecycle of Regulatory Submissions translation and localization projects to completion.Key responsibilities...


  • Madrid, Madrid, España IQVIA A tiempo completo

    Regulatory Submissions Project ManagerAt IQVIA, we are seeking a highly skilled Regulatory Submissions Project Manager to join our team. As a key member of our Project Management team, you will be responsible for coordinating and managing the full lifecycle of Regulatory Submissions translation and localization projects to completion.Key...


  • Madrid, Madrid, España Iqvia A tiempo completo

    Job SummaryThe Senior Manager Regulatory Submissions Process Development will lead a worldwide delivery team within IQVIA Translations. This team is responsible for developing and harmonizing the Regulatory Submissions Process. The ideal candidate will have experience working with QRDs, CTDs, SmPC, PIL, and other regulatory materials for EMA, SwissMedic,...


  • Madrid, Madrid, España IQVIA A tiempo completo

    Regulatory Submissions Director Opportunity at IQVIAThis is a key role for a seasoned professional who can lead a team of project managers in regulatory submissions. The successful candidate will have experience in managing teams, processes, and projects in the life sciences industry.Responsibilities:Lead a team of project managers in regulatory...


  • Madrid, Madrid, España Iqvia A tiempo completo

    Associate Director – Regulatory SubmissionsThe Associate Director – Regulatory Submissions is a key leadership role within IQVIA Translations, responsible for overseeing the development and harmonization of the Regulatory Submissions Process. This individual will lead a worldwide delivery team, ensuring high-quality deliverables for all Regulatory...


  • Madrid, Madrid, España Https:Www.Energyjobline.ComSitemap A tiempo completo

    Job Title: Associate Director, Translations Regulatory Submissions Project ManagementJob Summary:The Associate Director – Regulatory Submissions is a key leadership role within IQVIA Translations, responsible for leading a worldwide Regulatory Submissions delivery team. This team is responsible for the development and harmonization of the Regulatory...


  • Madrid, Madrid, España Https:Www.Energyjobline.ComSitemap A tiempo completo

    Regulatory Submissions Director Job DescriptionThe Associate Director, Regulatory Submissions is responsible to lead a worldwide Regulatory Submissions delivery team within IQVIA Translations.Key Responsibilities:Lead a team of Regulatory Submission Team Leaders to ensure the whole team meets and exceeds their monthly and yearly goals and...


  • Madrid, Madrid, España Iqvia A tiempo completo

    Key Responsibilities:• Lead a worldwide Regulatory Submissions delivery team within IQVIA Translations.• Develop and harmonize the Regulatory Submissions Process.• Ensure the team meets and exceeds monthly and yearly goals and objectives.• Implement processes to improve efficiency and ensure high-quality deliverables for Regulatory Submissions...


  • Madrid, Madrid, España IQVIA A tiempo completo

    IQVIA Translations Regulatory Submissions LeaderThis position is responsible for leading a worldwide Regulatory Submissions delivery team within IQVIA Transmissions. The team is in charge of developing and harmonizing the Regulatory Submissions Process.Key responsibilities include leading Regulatory submission Team Leaders, ensuring the whole team meets and...


  • Madrid, Madrid, España Iqvia A tiempo completo

    Job DescriptionIQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are seeking a skilled Translation Project Manager - Regulatory Submissions to join our team.Responsibilities:Coordinate and manage multiple Regulatory Submissions translation and localization projects...


  • Madrid, Madrid, España Iqvia A tiempo completo

    About the RoleThe Associate Director Regulatory Submissions is responsible for leading a worldwide delivery team within Iqvia Translations. This team is in charge of the development and harmonization of the Regulatory Submissions Process.Key Responsibilities:Lead Regulatory submission Team Leaders under his / her remit and ensure the whole team meets and...


  • Madrid, Madrid, España Iqvia A tiempo completo

    Job SummaryThe Associate Director, Translations Regulatory Submissions Project Management will lead a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is responsible for the development and harmonization of the Regulatory Submissions Process.Key ResponsibilitiesLead Regulatory submission Team Leaders under his/her remit and...


  • Madrid, Madrid, España IQVIA A tiempo completo

    Regulatory Submissions Team Lead OpportunityThe Associate Director – Regulatory Submissions is responsible for leading a worldwide Regulatory Submissions delivery team within IQVIA Translations.This team is in charge of the development and harmonization of the Regulatory Submissions Process.The Associate Director – Regulatory Submissions has experience...


  • Madrid, Madrid, España Https:Www.Energyjobline.ComSitemap A tiempo completo

    Job SummaryThe Associate Director – Regulatory Submissions is a key leadership role within IQVIA Translations, responsible for leading a worldwide Regulatory Submissions delivery team. This team is in charge of developing and harmonizing the Regulatory Submissions Process, working with QRDs, CTDs, SmPC, PIL, and other regulatory materials for EMA,...


  • Madrid, Madrid, España Medpace A tiempo completo

    Job SummaryWe are seeking a Regulatory Submissions Coordinator to join our Clinical Operations team in Madrid. This position plays a key role in the clinical trial management process at Medpace.ResponsibilitiesPrepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees;Ensure submissions comply with...


  • Madrid, Madrid, España Medpace A tiempo completo

    Clinical Operations at Medpace is growing rapidly, and we are seeking a full-time Regulatory Submissions Coordinator to join our team in Madrid. This role plays a key part in the clinical trial management process. If you want to develop your career further, this is the opportunity for you.Responsibilities:- Prepare, review, and file initial clinical trial...


  • Madrid, Madrid, España Medpace A tiempo completo

    Job SummaryWe are seeking a skilled Regulatory Submissions Coordinator to join our Clinical Operations team in Madrid. This role plays a crucial part in the clinical trial management process at Medpace.Key ResponsibilitiesPrepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees.Ensure submissions comply...


  • Madrid, Madrid, España Innovaderm Research A tiempo completo

    Job SummaryThe Senior Regulatory Affairs Manager will oversee the Regulatory Affairs group in assigned regions, ensuring services are conducted according to Innovaderm's standard operating procedures, applicable regulations, and good clinical practices. This role requires leadership on regulatory activities, planning, and assigning work, overseeing direct...