Senior Manager, Regulatory Affairs

Scancell; Oxford; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

Scancell Ltd in the United Kingdom seeks a Senior Manager, Regulatory Affairs to shape global regulatory strategy across late-phase development and to oversee regulatory submissions with CROs and external partners.

You will provide hands-on regulatory planning, interactions with health authorities, and guidance to cross-functional teams to drive delivery while ensuring compliance and readiness for inspections. The role is hybrid and fast-paced within a biotech environment.

Qualifications

• Undergraduate degree in Life Sciences or related field.
• Significant experience in Regulatory Affairs within pharma/biotech.
• Strong experience in regulatory operations including submissions and health authority interactions.
• Experience supporting late-phase clinical development programmes.

Responsibilities

• Develop and implement global regulatory strategy across major jurisdictions.
• Lead health authority interactions, submissions, and responses to agency questions.
• Oversee CROs and external providers, ensuring timely and compliant delivery.
• Maintain regulatory documentation and governance across development programmes.
• Provide day-to-day leadership and regulatory guidance to the team.

Skills

Regulatory affairs

Regulatory planning

Submission management

Cross-functional collaboration

Project management

Regulatory strategy

Communication

Risk management

Education

Undergraduate degree in Life Sciences or related

Job description

Post Title: 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.

Qualifications

·Undergraduate degree in a relevant scientific or pharmaceutical discipline, such as

Life Sciences, Pharmacy, Chemistry, Biology or a related field.

·Significant experience in Regulatory Affairs within the pharmaceutical, biotechnology or life sciences industry, with substantial experience supporting clinical-stage development programmes.

·Strong experience in regulatory operations and execution, including regulatory planning, submission preparation and management, health authority correspondence, responses to agency questions and management of regulatory commitments.

·Demonstrable experience supporting late-phase clinical development programmes and preparing for key regulatory milestones.

·Experience working with major health authorities, including the FDA, EMA, MHRA and/or other relevant international agencies.

·Experience contributing to regulatory strategy and development plans, with the ability to translate regulatory requirements into practical recommendations for cross-functional teams.

·Experience leading or supporting health authority interactions, including preparation of meeting requests, briefing packages, responses and follow-up activities.

·Experience working effectively within a predominantly outsourced operating model, including management and oversight of CROs, consultants and other external regulatory service providers.

· Strong understanding of applicable regulatory requirements and guidance governing clinical development and marketing applications in relevant jurisdictions.

·Demonstrable experience working cross-functionally within a development organisation.

· Experience developing, implementing or improving regulatory processes, SOPs, systems and governance within a growing organisation.

·Strong organisational and project management skills, with the ability to manage multiple regulatory activities and priorities simultaneously and deliver to demanding timelines.

· Excellent written and verbal communication skills, with the ability to communicate regulatory requirements and recommendations clearly to both regulatory and non-regulatory stakeholders.

·Demonstrable ability to work independently, exercise sound regulatory judgement and proactively identify and address regulatory risks and issues.

·A pragmatic, flexible and hands-on approach, with the ability to operate effectively in a

fast-paced, resource-conscious biotech environment.

Salary: Competitive salary and comprehensive employee benefits