Regulatory Submissions Specialist
hace 1 mes
Job Summary
We 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 Responsibilities
- Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees.
- Ensure submissions comply with applicable regulations and guidance documents.
- Advise sponsors on changing regulations and compliance requirements.
- Track submissions and ensure timely filing of documents.
- Collection of essential documents and preparation of essential documents packages for drug release.
- Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities.
Requirements
- A minimum of a Bachelor's degree in Life Sciences is required.
- One year of work experience as a Regulatory Submissions Coordinator and/or experience in study start-up tasks is desirable.
- Hands-on experience preparing, reviewing, and submitting regulatory documentation is beneficial.
- Excellent organizational and prioritization skills, great attention to detail.
- Knowledge of Microsoft Office.
- Fluency in English.
About Medpace
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through our scientific and disciplined approach.
Why Medpace?
At Medpace, we are committed to making a difference in the lives of patients and families affected by disease. We offer a dynamic work environment, competitive compensation and benefits package, and opportunities for professional growth and development.
-
Regulatory Submissions Specialist
hace 1 mes
Madrid, Madrid, España Medpace A tiempo completoJob 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...
-
Regulatory Submissions Specialist
hace 1 mes
Madrid, Madrid, España Medpace A tiempo completoClinical 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...
-
Regulatory Submissions Director
hace 3 semanas
Madrid, Madrid, España Https:Www.Energyjobline.ComSitemap A tiempo completoRegulatory 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...
-
Regulatory Submissions Director
hace 1 semana
Madrid, Madrid, España IQVIA A tiempo completoIQVIA 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...
-
Regulatory Submissions Director
hace 3 semanas
Madrid, Madrid, España IQVIA A tiempo completoRegulatory 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 completoRegulatory 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...
-
Regulatory Submissions Project Management Director
hace 3 semanas
Madrid, Madrid, España Iqvia A tiempo completoAbout 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...
-
Regulatory Submissions Project Management Expert
hace 1 semana
Madrid, Madrid, España Iqvia A tiempo completoKey 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 completoAssociate 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 completoJob 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...
-
Regulatory Submissions Project Manager
hace 1 mes
Madrid, Madrid, España IQVIA A tiempo completoRegulatory 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 completoRegulatory 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...
-
Senior Regulatory Submissions Project Manager
hace 1 semana
Madrid, Madrid, España IQVIA A tiempo completoAt 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 RoleThis challenging role requires a seasoned project manager with expertise in managing...
-
Regulatory Affairs Specialist
hace 1 mes
Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJob Title: Regulatory Affairs SpecialistThe Regulatory Affairs Specialist at Zentiva Group, a.s. is accountable for managing the Regulatory Affairs agenda at country level. This includes providing an efficient and proactive Regulatory service to meet business objectives, supporting commercialization of products, ensuring agility in daily interaction with...
-
Madrid, Madrid, España Iqvia A tiempo completoJob 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 Https:Www.Energyjobline.ComSitemap A tiempo completoJob 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 Iqvia A tiempo completoJob 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...
-
Regulatory Specialist
hace 3 semanas
Madrid, Madrid, España Precision Medicine Group A tiempo completoJob DescriptionPrecision for Medicine is a cutting-edge CRO that integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences. As we continue to grow, we are seeking a Regulatory and Start-Up Specialist to join our team in Spain. This position offers the opportunity to work fully from home. Key...
-
Regulatory Risk Specialist
hace 4 semanas
Madrid, Madrid, España Revolut Ltd A tiempo completoAbout the RoleThe Legal Department at Revolut is a key component of our business, supporting all other teams and helping us achieve our goals.This role sits within the Regulatory Response & Investigations team, providing specialist direction and support on contentious regulatory issues and internal investigations across the Revolut Group.You will work on a...
-
Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Iqvia A tiempo completoRegulatory Affairs Role OverviewAs a Regulatory Affairs Specialist at IQVIA, you will play a critical role in supporting clinical trial and marketing authorization activities for both internal and external clients. Your expertise will be instrumental in preparing and reviewing regulatory submissions to ensure compliance with regulatory requirements.Key...