Global Regulatory Lead — Oncology & Biotech

Proclinical; Cookham Dean; On-site; GBP 90,000 - 120,000; Full time

Job summary

Proclinical is seeking a Senior Regulatory Consultant to provide strategic and operational regulatory support for oncology and biotechnology products across international markets. You will act as a key member of EU and Global Regulatory Teams, developing and executing regulatory strategies for post-approval activities and lifecycle management.

The role requires strong expertise in EU/global regulatory frameworks, post-approval submissions, and cross-functional collaboration, with a focus on

Qualifications

• Extensive experience in Regulatory Affairs within the biotechnology/pharmaceutical industry.
• Proven expertise as a Global Regulatory Lead or in global regulatory strategy for innovative products.
• Strong knowledge of EU and global regulatory frameworks.
• Significant experience in post-approval lifecycle management and supporting marketed products.
• Proficiency in European regulatory procedures, including variations, renewals, labelling updates, and PSURs.
• Ability to assess complex regulatory challenges and develop practical, strategic solutions.
• Experience reviewing and approving regulatory documentation for international markets.
• Excellent communication, negotiation, and stakeholder management skills.

Responsibilities

• Act as a member of EU and Global Regulatory Teams for assigned commercial programs.
• Develop and execute global regulatory strategies for post-approval products.
• Provide strategic regulatory guidance to cross-functional teams and stakeholders.
• Review and approve regulatory documents and submissions for global markets.
• Support regional regulatory teams, ensuring alignment with global objectives.
• Participate in Health Authority interaction planning and address regulatory queries.
• Represent Regulatory Affairs within multidisciplinary product teams.
• Contribute regulatory insights during quarterly safety review meetings and benefit-risk discussions.
• Identify regulatory risks, challenges, and opportunities, proposing actionable solutions.
• Lead EU lifecycle management activities, including variation submissions and regulatory procedures.
• Oversee labelling updates and implementation across European markets.
• Prepare and coordinate Periodic Safety Update Reports (PSURs) and renewal submissions.
• Maintain Marketing Authorisations and ensure ongoing regulatory compliance.
• Manage regulatory aspects of clinical trial activities, including substantial amendments.
• Provide guidance on emerging EU regulatory requirements and their impact on product strategy.

Skills

Global regulatory leadership

EU regulatory knowledge

Post-approval lifecycle management

Regulatory submissions

PSURs & labelling updates

Regulatory strategy development

Stakeholder management

Cross-functional collaboration

Job description

Proclinical is seeking a Senior Regulatory Consultant to provide strategic and operational regulatory support for oncology and biotechnology products across international markets. You will act as a key member of EU and Global Regulatory Teams, developing and executing regulatory strategies for post-approval activities and lifecycle management.

The role requires strong expertise in EU/global regulatory frameworks, post-approval submissions, and cross-functional collaboration, with a focus on