Clinical Associate Regulatory Submissions

vor 2 Wochen

Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

Clinical Associate Submissions – Regulatory

Homebased

Austria, Switzerland

IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.

Job Overview

Position requires EU CTR experience for Germany and Austria, local language proficiency, and knowledge of national requirements. Certain submission tasks mandate a local address. Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

As Regulatory & Start-Up Specialist, you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.

You will also ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.

You will prepare submission documents and submit to regulatory bodies.

You will perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions, along with distributing completed documents to sites and internal project team members.

You will also prepare site documents and review for completeness and accuracy, along with reviewing, tracking, and following up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents, in line with project timelines.

Coupled with informing team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites, and providing local expertise to SAMs and project team during initial and on-going project timeline planning. Along with performing quality control of documents provided by sites.

You may also act as an SME on specific subjects, mentor junior CSAs, and have a sponsor-facing role.

Qualifications

B Sc degree in Health Sciences or related field.

1 - 3 years' relevant clinical research experience, specifically in submissions.

Experience in EUCTR and CTIS submission procedures, feasibility and Country Inform Consent adaptation for DACH regions.

Experience in Site Contract negotiations with DACH sites.

Experience in medical device submissions is beneficial.

In-depth knowledge of clinical systems, procedures, and corporate standards.

Skills

Good negotiating and communication skills in local language.

Effective communication, organizational, and interpersonal skills.

Ability to work independently and to effectively prioritize tasks.

Ability to manage multiple projects.

Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

Understanding of regulated clinical trial environment and knowledge of drug development process.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

  • Clinical Associate Regulatory Submissions

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    Basel, Switzerland | Full time | Home-based | R1522611Job available in additional locationsClinical Associate Submissions – RegulatoryHomebasedAustria, SwitzerlandIQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture,...

  • Associate Director, Global Regulatory Operations

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz Ultragenyx Vollzeit

    Why Join Us?Be a hero for our rare disease patientsAt Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go –...

  • Clinical Research Associate or SrCRA

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    Join IQVIA as aClinical Research Associate /Sr CRA (m/f/d) home-based throughout Switzerlandin oursingle sponsor department, and advance your career in clinical research. You'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our clients. Whether you're just starting out or...

  • Regulatory Affairs Associate

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz nemensis ag Schweiz Vollzeit

    Regulatory Affairs Associate (m/w/d) 100%Make Your Mark in Global Pharmaceutical Regulatory AffairsDuration : 2 years (temporary)Location : BaselType : Temporary positionSalary : CHF 60.00 / h to CHF 72.00/hAbout Our ClientFor our client, a leading global pharmaceutical company based in Basel's renowned BioValley region, we are seeking a dedicated...

  • Global Clinical Trial Coordinator

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client's project team in the execution of early clinical trials. Joining our team offers the opportunity to work on innovative projects in a dynamic environment. You will support trial preparation, documentation, and coordination, ensuring...

  • Global Clinical Trial Coordinator

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client's project team in the execution of early clinical trials. Joining our team offers the opportunity to work on innovative projects in a dynamic environment. You will support trial preparation, documentation, and coordination, ensuring...

  • Regulatory Contractor

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz Barrington James Vollzeit

    Job DescriptionRegulatory Contractor – full-time 6 months contract (remote)We are seeking a Regulatory Affairs Contractor to support one of our small biotech clients, including the preparation and submission of initial Marketing Authorization Applications (MAAs).September start dateFully remote, but preference to have candidates based in Spain, Poland or...

  • Regulatory Affairs Associate

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz RM Group (Switzerland) Vollzeit

    Regulatory Affairs Associatevacancy for our Basel based client in the Pharma sector.Your tasks:Provide operational support to Regulatory Affairs (RA) Regions.Organise and coordinate business-critical documents for regulatory submissions.Manage the process for Apostille or legalisation of documents as required.Act as the Single Point of Contact with external...

  • Regulatory Affairs Associate

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Actalent Vollzeit

    Our client, a leading global pharmaceutical company, is looking for aRegulatory Affairs Associateto support key submission activities across international markets. This role is ideal for someone who enjoys coordination, thrives in a structured environment, and wants to contribute to bringing life‑changing medicines to patients worldwide.*Please note that...

  • Regulatory Affairs Associate

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Regulatory Affairs AssociateOur client, an innovative and dynamic...