Clinical Trial Expert
4 days ago
Our team is seeking a highly skilled and experienced Regulatory Affairs Manager to join our global operations.
About the JobThe successful candidate will be responsible for providing regulatory services to support international multinational clinical trials in accordance with client requests.
This includes preparing, reviewing, and compiling regulatory submissions, liaising with regulatory authorities, and providing expert advice on regulatory questions/issues.
Requirements- Bachelor's Degree, preferably in life sciences or pharmacy, or equivalent experience.
- Minimum of 5 years of relevant experience in regulatory affairs within clinical research.
- Strong understanding of Phase II–III.
- Knowledge of Good Clinical Practice (GCP) regulations, ICH guidelines, and Clinical Trial Regulations.
- Ability to work independently and collaboratively within a matrix organization.
- Excellent written and verbal communication skills in English.
- Strong organizational skills and ability to manage multiple tasks effectively.
- Proficiency in Microsoft Office Suite (Word, Excel, MS Project).
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