Senior Regulatory Affairs Professional
2 weeks ago
Regulatory Affairs Role
We are seeking a highly skilled Regulatory Affairs professional to support our Clinical Trial Submissions (CTS) group.
This role is ideal for someone with experience in regulatory affairs and a strong background in Clinical Trial Submissions.
Key Responsibilities
- Identify and coordinate international, national, and local regulatory requirements for clinical trial submissions across various countries.
- Draft, review, and ensure the quality of all documents related to Clinical Trial Application (CTA) dossiers in accordance with local and regional regulations.
- Provide regulatory review of core study documents (e.g., protocols, Investigator's Brochure, informed consent forms, and labels) to ensure compliance with regulatory standards.
- Perform quality control (QC) on CTA packages before submission to regulatory authorities.
- Draft and QC responses to client inquiries and provide timely, accurate regulatory guidance.
- Liaise with regulatory authorities and service providers to support the submission process.
- Lead or participate in regular video/teleconferences with clients to provide status updates on the regulatory progress of their studies.
Requirements
- 4+ years of experience in Regulatory Affairs, with a specific focus on Clinical Trial Submissions (CTS).
- Deep understanding of regional and local regulatory requirements for clinical trials.
- Strong organizational and communication skills.
- Experience working with regulatory authorities and managing client relationships in a professional setting.
- A proactive approach to problem-solving, with strong attention to detail.
About VCLS
VCLS is a innovative and growing company that values regulatory science and compliance.
We are committed to delivering high-quality clinical trial submissions and regulatory services to our clients.
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