Senior Manager, Clinical Trials Strategy & Submissions

Responsibilities

• Develop and lead the strategy and execution of a portfolio of Clinical Trial Applications (CTAs) including increasingly complex trial designs with elevated regulatory risk, involving high-priority assets, new therapeutic areas, adaptive trial designs, decentralized models, and evolving regulatory requirements.
• Develop agile regulatory strategies that include risk assessment and actionable mitigation measures, provide strategic advice on submission planning to drive acceleration and successful execution of global CTAs across multiple markets.
• Design and implement global CTA submission strategy that aligns with the overarching regulatory strategy and region-specific requirements and ensure that risks and issues are highlighted to the Global Regulatory Project Team (GRPT), study teams and functional leadership.
• Lead CTA-specific scientific-advice procedures, advising study teams and management on available options and the optimal timing and approach for their use.
• Assess scientific data against CTA regulatory requirements; identify gaps, develop mitigations, and lead resolution and escalation of complex regulatory or feasibility and operational issues.
• Define country and regional strategies (geostrategy) based on regulatory expertise, country-specific trends and risk outlook, and acceleration opportunities.
• Serve as the EU Agency Point of Contact (APOC) for EU CTR submissions, leading regulatory-agency interactions, negotiations, and relationship building.
• Lead discussions with and adapt the expertise and knowledge from senior leaders, including Therapeutic Area Vice-President (TA VP) Heads, Executive Medical Directors (MDs), etc., to shape the optimal regulatory strategy.
• Lead review and provide regulatory input on clinical trial submission-related documents, such as the Investigator's Brochure (IB) and Clinical Study Protocols.
• Serve as the Clinical Trial Submission & Strategy subject matter expert in cross-functional forums and study teams.
• Educate stakeholders across therapeutic areas and programmes on regulatory requirements, risks and mitigations, timelines, strategies, and insights from trends in regulatory agency questions and requests for information (RFIs).
• Ensure approved company CTA processes and regulatory SOPs are followed, and deliverables are completed within agreed timelines.
• Ensure compliance with current clinical trial legislation including EU CTR, IVDR, MDR, etc.
• Monitor and track key project milestones, identify issues and changes to assigned stakeholders and communicate updates to management.
• Support audit and inspection readiness activities when applicable.
• Maintain regulatory intelligence on clinical trials, reviewing and critically assessing the impact of evolving legislation and provide timely updates and training to stakeholders.
• Facilitate and ensure effective cross-functional communication of regulatory processes and support affiliate training on regulatory procedures and systems.
• Facilitate consensus among management, subject matter experts (SMEs), quality systems, and peers to identify best practices and drive improvements.
• Ensure all relevant databases and activity trackers are populated accurately within agreed timelines.
• Provide support for Regulatory and/or non-Regulatory systems that are critical for regulatory submission and maintenance activities, and QP release.
• Foster a culture of continuous process-improvement initiatives within CTS and cross-functionally.
• Provide regulatory interface concerning clinical trials with Quality Assurance, Regulatory Operations, Clinical Study Leadership, R&D Quality Assurance, and Supply Chain.
• Modify and develop company procedures as necessary; participate in and/or coordinate the development of Standard Operating Procedures (SOP).
• Lead, coach, and develop a team of Clinical Trial Strategy & Submissions Specialists and Senior Specialists, overseeing workload distribution, performance management, and career and talent development.

Qualifications

• A Bachelor degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
• Minimum of 6 years' experience in the pharmaceutical industry with at least 5 years' experience in Regulatory Affairs including extensive global clinical trial experience.
• Minimum of 1 year of the required experience in leadership and management.
• Experience of managing multi-national programmes of CTAs.
• Excellent understanding of the legislation governing the conduct of global clinical trials including EU Clinical Trials Regulation (EU CTR) and other applicable Clinical Trial Regulations, GMP, GCP, ICH guidelines, and other relevant standards relating to the manufacture and release of clinical trial supplies.
• Knowledge and experience of medical device legislation as it relates to clinical trials is preferred.