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Regulatory Affairs Specialist
7 days ago
As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in different Therapeutic Areas.
We are currently looking for a Regulatory Affairs Manager with global clinical expertise in regulatory affairs. The successful candidate will be responsible for providing regulatory services to support international multinational clinical trials.
The Regulatory Affairs Manager will work closely with the project delivery organization to prepare, conduct, and complete Regulatory Affairs tasks in assigned Study Teams.
Required Skills and Qualifications
- 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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