Thermo Fisher Scientific dezvoltă și furnizează tehnologii, produse de laborator și servicii farmaceutice care sprijină cercetarea științifică și asistența medicală. Activitatea sa acoperă cercetarea în domeniul științelor vieții, rezolvarea problemelor analitice, creșterea productivității laboratoarelor, diagnosticarea, precum și dezvoltarea și producția de terapii. Compania își deservește clienții printr-o echipă globală și un portofoliu de mărci care include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon și PPD. Oportunitățile de carieră includ activitățile științifice, medicale, de producție, logistice și de servicii care susțin aceste oferte.
Senior Regulatory Affairs Specialist – Regulatory Liaison, Croatia Remote
Senior regulatory affairs professional supporting global submissions and clinical trial programs at Thermo Fisher Scientific. The role advises project teams and coordinates regulatory strategy with health authorities.
Descriere
- Deliver regulatory guidance and manage projects supporting regulatory affairs services
- Serve as a regulatory affairs liaison for internal stakeholders
- Manage daily Regulatory Affairs Department operations, including regulatory document assessments
- Prepare and compile submissions for global regulatory applications
- Perform quality-control reviews of final submission packages
- Coordinate with PPD project teams and health authorities on regulatory strategy and submission activities
- Build and maintain effective working relationships with project managers and project team members
- Guide project teams on responsibilities related to regulatory strategy and submission activities
- Serve as the primary liaison between the Regulatory Affairs Department and project teams for assigned projects
Cerințe
- Bachelor’s degree
- A degree in pharmacy or life sciences is advantageous
- Prior regulatory experience is preferred; equivalent relevant work experience, higher education, or a combination may be considered
- Previous regulatory affairs experience
- Understanding of global regulatory application requirements, timelines, and processes is valuable
- Experience compiling and submitting clinical trial applications in the EU and other countries is advantageous
- Excellent spoken and written English communication skills
- Computer proficiency, including Microsoft Office
- Experience with clinical trial applications such as eTMF and CTMS is advantageous
- Strong organizational and planning abilities
- Ability to manage multiple project tasks
- Demonstrated ability to work effectively within multinational teams
- Strong problem-solving skills and attention to detail
Beneficii
- Fully remote work arrangement
- Standard 40-hour office workweek