Global Clinical Trials Regulatory Specialist
Há 3 dias
Thermo Fisher Scientific, a leading global biotechnology company, is seeking an experienced Regulatory Affairs Specialist to join our Global Clinical Trial team. With a competitive salary of $120,000 per annum, this role offers a unique opportunity to contribute to the development and implementation of regulatory strategies for clinical trials worldwide.
About the Role:
We are looking for a skilled and dedicated professional to lead discussions and coordinate regulatory strategies globally on assigned clinical trials, studies, and projects. As a key member of our team, you will work closely with internal and external stakeholders to provide innovative solutions and expert regulatory guidance. Your excellent analytical, investigative, and problem-solving skills will be essential in ensuring compliance with global/regional/national country requirements and regulatory affairs procedures.
Key Responsibilities:
- Preparation and assembly of global regulatory submissions
- Interacting with sponsors to ensure compliance with regulatory requirements
- Review and assess clinical trial regulatory documents and scientific literature
- Manage project teams and prepare deliverables
- Participate in launch meetings, review meetings, and project team meetings
Required Skills and Qualifications:
To be successful in this role, you will need:
- Bachelor's degree or advanced degree in a relevant field (e.g., life sciences, pharmacy, law)
- Previous experience in regulatory affairs, preferably in a global clinical trials setting
- Excellent command of the English language (written and oral) as well as local language where applicable
- Exceptional interpersonal skills to work effectively in a team environment
- Advanced computer skills, including Microsoft Word, Excel, PowerPoint, and capable of learning new technologies
What We Offer:
In addition to a competitive salary, we offer a comprehensive benefits package, flexible working culture, and opportunities for professional growth and development. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Join us in accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need.
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