Senior Specialist, Clinical Trial Strategy & Submissions (CTS)

Role Overview

As the Senior Specialist, Clinical Trial Strategy & Submissions (CTS), you will serve as a regulatory expert responsible for providing global regulatory expertise for clinical trials. You will act as the primary interface between global functions and regional affiliates to deliver robust clinical development regulatory strategies, operations, and submission outcomes.

This role is ideal for a proactive, solution-driven regulatory professional with hands-on experience managing Clinical Trial Applications (CTAs) and navigating complex global regulatory frameworks.

Key Responsibilities

• CTA Management & Portfolio Operations: Manage a portfolio of Clinical Trial Applications (CTAs), including the end-to-end preparation, coordination, and distribution of documentation for initial CTAs and ongoing lifecycle maintenance activities (e.g., substantial amendments, end-of-trial notifications).

• Regulatory Strategy & Advisory: Provide expert guidance on regulatory submission strategies, country-specific requirements, and operational support for submission preparation. Review and input into key clinical trial documents, including Investigator's Brochures (IB) and study protocols.

• Subject Matter Expertise (EU CTR & Global Frameworks): Serve as a Subject Matter Expert (SME) on EU Clinical Trials Regulation (EU CTR) submissions, including complex and platform trial designs. Define CTR transition strategies and guide cross-functional teams while refining processes based on lessons learned.

• Scientific Advice & Stakeholder Engagement: Lead CTA-specific scientific advice procedures, advising study teams and management on strategic options and timing.

• Process Compliance & Milestone Tracking: Ensure all company CTA processes adhere to agreed timelines and quality standards. Monitor key study milestones (actual vs. planned), proactively identifying and communicating potential risks or changes to management and assigned stakeholders.

• Regulatory Intelligence & Tracking: Review and stay abreast of global regulatory intelligence relating to clinical trials. Maintain and populate regulatory tracking databases and systems to meet compliance and reporting requirements.

• Inspection Readiness & Continuous Improvement: Support audit and regulatory inspection readiness activities. Provide operational and technical support (including document formatting/tools) for the CTS team.

Requirements & Qualifications

• Education:

  • Bachelor's degree in Medicine, Pharmacy, Biology, Chemistry, Pharmacology, or a related Life Sciences discipline required.

  • An advanced degree (Master's or Ph.D.) in Life Sciences is preferred.

• Experience:

  • Minimum of 3 to 5 years of hands-on Clinical Trial Application (CTA) experience, preferably involving global clinical trial submissions to health authorities.

  • Proven experience working effectively within a complex, cross-cultural matrix organization.

• Regulatory Knowledge: Deep understanding of global clinical trial regulatory frameworks, including EU CTR process and submission requirements.

• Core Competencies:

  • Strong project management skills with the ability to prioritize and execute multiple concurrent activities in line with study deadlines.

  • Critical reasoning and problem-solving skills, with the ability to identify issues early and elevate them appropriately.

  • Proactive, solution-oriented approach with high self-initiative and independence.

  • Excellent written and verbal communication, presentation, and interpersonal skills in English.

• Technical Skills: Proficient in standard computer applications (MS Word, Excel, PowerPoint, Adobe Acrobat) and experience utilizing global regulatory databases/trackers