Director EMEA Regulatory Leader – Solid Tumor Oncology

TN United Kingdom; High Wycombe; On-site; GBP 90,000 - 130,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Director EMEA Regulatory Leader for Solid Tumor Oncology in High Wycombe. This role involves developing regulatory strategies, leading a team, and ensuring compliance with regulatory submissions. The ideal candidate will have extensive experience in EU regulatory affairs and a strong background in life sciences.

Qualifications

• 10+ years of extensive EU regulatory experience in drug development and commercialization.

Responsibilities

• Develop innovative regulatory strategies for new medicines.
• Lead and coach a team of up to 6 regulatory professionals.
• Ensure timely and compliant submission of Clinical Trial Applications and Marketing Authorization Applications.

Skills

Influencing

Conflict Resolution

Communication

Organization

Strategic Thinking

Education

Masters' degree in life sciences

Job description

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Director EMEA Regulatory Leader – Solid Tumor Oncology, High Wycombe

Client: Johnson and Johnson

Location: High Wycombe, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com

Job Function and Sub-Function

Regulatory Affairs

Job Location

High Wycombe, Buckinghamshire, United Kingdom

Key Responsibilities

• Develop innovative regulatory strategies for new medicines.
• Develop and drive implementation of regional regulatory strategies supporting global development plans.
• Lead, develop, and coach a team of up to 6 regulatory professionals.
• Establish strong relationships with regulators and act as the primary contact with EMEA agencies.
• Ensure timely and compliant submission of Clinical Trial Applications (CTA) and Marketing Authorization Applications (MAA).
• Provide regulatory input throughout the product lifecycle.

Qualifications

• Masters' degree in life sciences or equivalent experience.
• Extensive EU regulatory experience (10+ years) in drug development and commercialization.
• Skills include influencing, conflict resolution, communication, organization, and strategic thinking.
• Excellent knowledge of English and therapeutic area expertise.