Principal Reg Affairs Specialist/Reg Affairs Manager - Cherkasy
1 місяць тому
Job summary
We are currently seeking a Principal Regulatory Affairs Specialist / Regulatory Affairs Manager to join our global Regulatory Affairs department.This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.
In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects.
You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance.
You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients.
You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement.
Qualifications
- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Knowledge of the global clinical trials landscape
Responsibilities
- preparation and assembly of global regulatory submissions (CTA)
- interacting with sponsors,
- review and assess clinical trial regulatory documents,
- review and assess scientific literature.
Skills
- Excellent command of the English language (written and oral) as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Experience in leading global regulatory projects for Clinical Trial Applications
Опис вакансії
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