Thermo Fisher Scientific ऐसी प्रौद्योगिकियाँ, प्रयोगशाला उत्पाद और फार्मास्युटिकल सेवाएँ विकसित तथा उपलब्ध कराती है, जो वैज्ञानिक अनुसंधान और स्वास्थ्य सेवा को समर्थन देती हैं। इसका कार्य जीवन विज्ञान अनुसंधान, विश्लेषणात्मक समस्याओं के समाधान, प्रयोगशाला उत्पादकता, निदान तथा उपचारों के विकास और निर्माण तक फैला हुआ है। कंपनी Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon और PPD सहित विभिन्न ब्रांडों के पोर्टफोलियो तथा एक वैश्विक टीम के माध्यम से ग्राहकों की सेवा करती है। इसके करियर अवसर इन उत्पादों और सेवाओं से जुड़ी वैज्ञानिक, स्वास्थ्य सेवा, विनिर्माण, लॉजिस्टिक्स और सेवा संचालन को शामिल करते हैं।
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.
विवरण
- 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
आवश्यकताएँ
- 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
लाभ
- Fully remote work arrangement
- Standard 40-hour office workweek