Regulatory Affairs Specialist for Clinical Trial Submissions
1 week ago
Clinical Trial Submissions Role Overview
We are expanding our Clinical Trial Submissions group at VCLS and seeking an experienced Regulatory Affairs professional to join our growing team. This role is ideal for someone with a strong background in Clinical Trial Submissions and a deep understanding of regional and local regulatory requirements.
Key Responsibilities:
- Identify and coordinate international, national, and local regulatory requirements for clinical trial submissions.
- Draft, review, and ensure the quality of documents related to Clinical Trial Application (CTA) dossiers.
- Provide regulatory review of core study documents, including protocols, Investigator's Brochure, informed consent forms, and labels.
- Perform quality control on CTA packages before submission to regulatory authorities.
- Maintain and update study status tracking tools and exchange information with clients and internal teams.
- Draft and QC responses to client inquiries and provide timely, accurate regulatory guidance.
- Collaborate with subject matter experts across various departments to ensure a seamless approach to projects.
Requirements:
- 4+ years of experience in Regulatory Affairs, with a focus on Clinical Trial Submissions.
- A deep understanding of regional and local regulatory requirements for clinical trials.
- Strong organizational and communication skills, with the ability to collaborate across departments.
- Experience working with regulatory authorities and managing client relationships.
- A proactive approach to problem-solving and strong attention to detail.
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