Senior Manager, Regulatory Affairs

Company: Scancell Ltd

Responsible To: Senior Vice President, Development

Location: Hybrid

Summary of Post

The Senior Manager, Regulatory Affairs will play a key role in supporting the Company's development programme as it progresses into late-phase clinical development. The role will contribute to the development and implementation of the Company's global regulatory and development strategy, providing regulatory expertise, practical insight and sound judgement to support programme decisions and define appropriate regulatory pathways across major jurisdictions, including the FDA, MHRA, EMA, Health Canada and TGA.

The role will have a strong operational focus, with significant responsibility for the planning, coordination and execution of regulatory activities across the development programme. Operating within a predominantly outsourced model, the Senior Manager, Regulatory Affairs will provide oversight and direction to CROs and other external regulatory service providers, monitoring delivery, quality and timelines and providing constructive challenge where appropriate. The role will retain internal responsibility and accountability for key regulatory activities and will be expected to remain hands-on in their delivery, including regulatory planning, submissions, health authority interactions, preparation and review of regulatory documentation, responses to agency questions, tracking of regulatory commitments and resolution of operational issues.

The Senior Manager, Regulatory Affairs will provide day-to-day management and support to the Regulatory Affairs team, including direct line management. The role will work closely with senior stakeholders on regulatory priorities, strategy and key programme decisions, while maintaining a strong focus on the effective execution and delivery of regulatory activities.

The role will work closely with internal cross-functional project and programme teams, providing regulatory expertise, advice and support and actively contributing to programme planning, decision-making and execution.

The Senior Manager, Regulatory Affairs will also contribute to the development and continuous improvement of the Company's regulatory infrastructure, processes, SOPs, systems and governance, supporting the Company's transition into late-stage development. The role will help ensure that regulatory activities are appropriately planned, tracked and documented and that the Company maintains a high level of regulatory and inspection readiness.

The successful candidate will be expected to work with pace, flexibility and pragmatism, proactively identify and manage regulatory risks and issues, and develop effective and proportionate solutions appropriate to a small, predominantly outsourced biotechnology organisation.

Key duties and responsibilities

• Contribute to the development and implementation of the Company's global regulatory and development strategy, providing regulatory input, expertise and practical recommendations to support programme decisions.
• Provide regulatory advice and support across the Company's development programme, including assessment of regulatory pathways and requirements and preparation for interactions with the FDA, MHRA, EMA, Health Canada and TGA.
• Lead and support health authority interactions within areas of responsibility, including meeting planning and strategy, preparation and review of briefing packages, submissions, responses to agency questions and follow-up activities.
• Take a hands-on role in regulatory operations, including regulatory planning, submission management, preparation and maintenance of regulatory documentation, agency correspondence, tracking of regulatory commitments and milestones, and other activities required to support the development programme.
• Manage and oversee the delivery of regulatory activities by CROs and external regulatory service providers, providing clear direction, monitoring progress and quality, and applying appropriate constructive challenge to ensure timely and effective delivery.
• Retain internal responsibility and accountability for assigned regulatory activities, ensuring that outsourced activities are appropriately planned, coordinated, documented and delivered in accordance with regulatory requirements and Company expectations.
• Review and contribute directly to key regulatory deliverables, ensuring they are accurate, consistent, high quality and aligned with the agreed regulatory strategy and development plans.
• Contribute to the development, implementation and continuous improvement of the Company's regulatory processes, SOPs, procedures and governance, ensuring they are practical, compliant, fit for purpose and proportionate to the Company's size, operating model and stage of development.
• Support the implementation and maintenance of effective systems for the planning, tracking and oversight of regulatory submissions, health authority interactions, commitments and key regulatory milestones.
• Support a high level of regulatory and inspection readiness, ensuring that relevant documentation, records, processes and systems are appropriately maintained and readily accessible, and supporting preparation for regulatory inspections and audits.
• Identify, assess and proactively manage regulatory risks, issues and opportunities, escalating significant matters as appropriate and proposing practical and timely solutions.
• Work collaboratively with other functions to ensure regulatory considerations are appropriately integrated into programme planning, decision-making and execution.
• Provide regulatory support to cross-functional project and programme teams, contributing to development plans, timelines, risk assessments, key decisions and deliverables, and ensuring regulatory requirements and dependencies are clearly understood and appropriately addressed.
• Act as a key internal regulatory subject matter expert, providing clear, pragmatic and solutions-focused regulatory advice to senior management and cross-functional teams.
• Build effective working relationships with internal stakeholders, CROs, consultants and other external partners to facilitate efficient and high-quality delivery of regulatory activities.
• Support the preparation of regulatory strategies, plans, briefing materials and other regulatory documents required to support programme development and decision-making.
• Maintain awareness of relevant regulatory guidance, legislation and evolving regulatory expectations, assessing their potential impact on the Company's development programme and communicating relevant implications to stakeholders.
• Contribute to the Company's regulatory knowledge and capability by sharing expertise, supporting colleagues and promoting consistent, effective and compliant regulatory practices.
• Operate effectively across strategic, tactical and operational levels, with a flexible, pragmatic and hands-on approach appropriate to a small, predominantly outsourced biotechnology organisation.