Elevate your career in regulatory affairs with a pivotal role in Clinical Trial Submissions. This role offers strategic support to CTS Strategy Leads, ensuring compliance and timely delivery in a versatile remote or hybrid work environment.
As a Regulatory Affairs Manager, you will be integral in preparing and compiling Clinical Trial Authorization (CTA) submissions. Your expertise in EU/UK Clinical Trial Regulations and ICH-GCP guidelines will drive quality control and document tracking efforts. Engage with cross-functional teams and CRO partners to manage timelines and enhance submission processes effectively.
Key Responsibilities:
• Prepare and compile CTA submission documents with quality control
• Track document provision and follow up with stakeholders
• Maintain detailed trackers for submission timelines
• Support submission-related meeting documentation and follow-ups
• Coordinate cross-functional alignment on submission requirements
Requirements:
• B...