Aktualne oferty pracy związane z Regulatory Affairs Specialist - Warszawa, Mazovia - Syneos Health, Inc.
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Regulatory Affairs Specialist
1 tydzień temu
The Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements related to clinical trials. This includes preparing and submitting documents to regulatory authorities, maintaining accurate records, and communicating with investigational sites and functional leads to resolve issues related to site activation and submissions.
Responsibilities
- Prepares and submits documentation to regulatory authorities, including Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions.
- Maintains accurate records of all submissions and track changes in regulatory requirements.
- Communicates with investigational sites and functional leads to resolve issues related to site activation and submissions.
- Develops and maintains procedures for regulatory compliance, including SOPs and WIs.
Requirements
- Bachelor's degree in a relevant field, such as life sciences or regulatory affairs.
- 3+ years of experience in regulatory affairs, preferably in a pharmaceutical or biotechnology industry.
- Strong knowledge of regulatory requirements, including ICH GCP, FDA regulations, and EMA guidelines.
- Excellent communication and interpersonal skills, with ability to work effectively with cross-functional teams.
- Ability to prioritize tasks and manage multiple projects simultaneously.
