Manager, Oncology Regulatory Strategy (Oncology)

Location: United Kingdom - Walton Oaks; hybrid work arrangement

Company

hirify.global develops medicines and vaccines with a focus on accelerating patient access and improving global health outcomes.

What you will do

• Represent the Rest of World region in regulatory sciences and contribute regional expertise to Global Regulatory Strategic Teams.
• Lead and implement regional regulatory strategies for assigned oncology projects and products in alignment with commercial objectives.
• Coordinate regulatory contributions including core labels, risk registers, line plans, clinical trial applications, marketing authorization applications, variations, and license renewals.
• Monitor regulatory plans, communicate progress and variances, and mitigate risks arising from technical data, changing objectives, or external developments.
• Develop aligned regional regulatory positions and communicate them to project teams, senior management, and business stakeholders.
• Maintain constructive relationships with health authorities, regulatory agencies, trade associations, and key opinion leaders.

Requirements

• Scientific degree; a higher degree is advantageous but not essential.
• Proven experience managing national or regional regulatory processes and drug registration activities, including clinical trial experience in at least one country.
• Experience serving as a national or regional regulatory liaison for products across therapeutic areas and stages of the product lifecycle is highly desirable.
• Knowledge of drug development practices, regulations, guidelines, and factors influencing the regulatory environment.
• Experience developing and implementing regulatory strategies, preparing and submitting INDs, CTAs, NDAs, or MAA/IRDs, and working with regulators and opinion leaders.
• Strong communication, presentation, negotiation, and stakeholder management skills, including communication with senior management.

Culture & Benefits

• Hybrid work arrangement at Walton Oaks in the United Kingdom.
• Flexible workplace culture supporting work-life harmony.
• Patient-centric environment guided by courage, joy, equity, and excellence.
• Inclusive workplace with reasonable adjustments available for disabled candidates.
• Digital transformation initiatives using data, modelling, and automation to accelerate drug discovery and development.