Global Regulatory Lead - Oncology & Biotech

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

Job summary

Proclinical is seeking a Senior Regulatory Consultant to shape global regulatory strategy for oncology/biotech products across international markets. The role covers EU and Global regulatory responsibilities, lifecycle management, and cross-functional team leadership in regulatory strategy.

The ideal candidate brings extensive Regulatory Affairs experience in biotech/pharma, strong EU/global framework knowledge, and a track record in post-approval activities, labeling updates, and PSURs.

Qualifications

• Extensive experience in Regulatory Affairs within biopharma or biotech.
• Global regulatory lead experience or global regulatory strategy demonstrated.
• Strong knowledge of EU and global regulatory frameworks.
• Significant post-approval lifecycle management and support for marketed products.
• Proficiency in EU regulatory procedures (variations, renewals, labeling updates, PSURs).

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 lead

EU regulatory knowledge

Post-approval lifecycle

PSURs

Regulatory submissions

Stakeholder management

Regulatory strategy

Job description

Proclinical is seeking a Senior Regulatory Consultant to shape global regulatory strategy for oncology/biotech products across international markets. The role covers EU and Global regulatory responsibilities, lifecycle management, and cross-functional team leadership in regulatory strategy.

The ideal candidate brings extensive Regulatory Affairs experience in biotech/pharma, strong EU/global framework knowledge, and a track record in post-approval activities, labeling updates, and PSURs.