The Clinical Trial Strategy & Submissions Senior Manager leads and develops a team of Specialists and Senior Specialists, providing global regulatory expertise and strategic direction for international clinical trials in over 60 countries. The role serves as a senior interface between global functions and affiliates to deliver clinical development regulatory strategy and execution that significantly impact business objectives and outcomes. The Senior Manager also acts as the primary regulatory contact for AbbVie and external regulators in Europe and international regions.

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. Effectively frames complex issues for decision-makers. Prepares and delivers effective management presentations that lead to actionable results.
• Make well-informed and strategic decisions that may impact clinical R&D deliverables on key geographic areas such as program timelines and quality, company reputation and credibility with regulatory agencies, downstream registrations, marketing authorisations, and market access outcomes.
• Lead review and provide regulatory input on clinical trial submission-related documents, such as the Investigator’s Brochure (IB) and Clinical Study Protocols, managed by other functions to ensure alignment with regulatory compliance, emerging regulatory trends and expectations across regions and countries.
• Serve as the Clinical Trial Submission & Strategy subject matter expert in cross-functional forums and study teams, acting as a key liaison with global and affiliate stakeholders to influence decisions and align strategy across functions. 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), while managing cross-functional expectations.
• 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 (actual vs. planned activities and timelines), identify issues and changes to assigned stakeholders and communicate updates to management in line with company procedures.
• 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 on resulting regulatory changes, as well as members of the CTS team.
• Facilitate and ensure effective cross-functional communication of regulatory processes and support affiliate training on regulatory procedures and systems; escalate any compliance or process gaps identified and drive resolution in collaboration with cross-functional teams.
• Facilitate consensus among management, subject matter experts (SMEs), quality systems, and peers to identify best practices and drive improvements in procedures, documentation, regulatory communications, and affiliate training.
• Ensure all relevant databases and activity trackers are populated accurately within agreed timelines and in line with compliance and reporting requirements. Provide support for Regulatory and/or non-Regulatory systems that are critical for regulatory submission and maintenance activities, and QP release.
• Complete required training and comply with company policies and procedures to meet internal and external process, statutory, quality, and business requirements in support of AbbVie Ltd.'s overall strategy and objectives.
• Foster a culture of continuous process-improvement initiatives within CTS and cross-functionally, using effective group facilitation to build consensus and collaborate with management, subject matter experts (SMEs), quality systems, and peers to design cross-functional solutions.
• Provide regulatory interface concerning clinical trials with Quality Assurance, Regulatory Operations, Clinical Study Leadership, R&D Quality Assurance, and Supply Chain to identify, resolve and elevate potential issues arising from regulatory approvals and maintenance of CTAs and/or compliance with AbbVie and industry standards. Modify and develop company procedures as necessary.
• Participate in and/or coordinate the development of Standard Operating Procedures (SOP), support SOP reviews and updates as needed.
• Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd.
• 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 in alignment with AbbVie’s ways of work, using available growth resources.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required