Global Regulatory Strategy Lead – Oncology & Biotech

Proclinical; Maidenhead; On-site; GBP 90,000 - 130,000; Full time

Job summary

Proclinical in the United Kingdom seeks a Senior Regulatory Consultant to steer global regulatory strategy for oncology and biotech portfolios, covering EU and international markets. You will work on lifecycle management, submissions, and cross-functional teams.

The role requires deep regulatory experience, strong communication, and the ability to navigate complex regulatory environments across geographies; you will lead variations, PSURs, labeling updates, and ensure compliance.

Qualifications

• Extensive experience in Regulatory Affairs within biotech/pharma.
• Proven track record as Global Regulatory Lead or in global regulatory strategy.
• Strong knowledge of EU and global regulatory frameworks.
• Experience enabling lifecycle management and post-approval activities.

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 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 strategy

Regulatory leadership

EU regulatory frameworks

Post-approval lifecycle management

Cross-functional collaboration

Regulatory submissions

Job description

Proclinical in the United Kingdom seeks a Senior Regulatory Consultant to steer global regulatory strategy for oncology and biotech portfolios, covering EU and international markets. You will work on lifecycle management, submissions, and cross-functional teams.

The role requires deep regulatory experience, strong communication, and the ability to navigate complex regulatory environments across geographies; you will lead variations, PSURs, labeling updates, and ensure compliance.