Director EMEA Regulatory Leader - Solid Tumor Oncology

Johnson and Johnson; High Wycombe; On-site; GBP 90,000 - 120,000; Full time

Job summary

A leading healthcare company is seeking a Director EMEA Regulatory Lead for Solid Tumor Oncology. This role involves developing regulatory strategies, leading a team, and ensuring compliance with regulations. The position offers a chance to impact healthcare positively across EMEA.

Qualifications

• 10+ years EU regulatory experience in drug development.
• Extensive experience across multiple therapeutic areas.

Responsibilities

• Develop innovative regulatory strategies for new medicines.
• Lead and coach a team of regulatory professionals.
• Establish strong relationships with regulators.

Skills

Influencing

Conflict Resolution

Communication

Project Management

Strategic Insight

Coaching

Education

Masters' degree in life sciences

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:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description:

Janssen GRA EMEA oncology is recruiting for a Director EMEA Regulatory Lead in the Solid Tumor Oncology Therapeutic areas (TA) to contribute to the development and registration of oncology products in Europe, the Middle East, and Africa (EMEA). The successful applicant will lead a team to develop and implement regulatory strategies to achieve efficient development and timely commercialization of innovative pharmaceutical products in compliance with applicable regulations and regional needs.

The position can be based in multiple locations in the EU with a Janssen office. The job provides an opportunity to work on small and large molecules in different oncology indications, contributing to healthcare one patient at a time!

Key Responsibilities:

• Develop innovative regulatory strategies for new medicines
• Develop and drive implementation of regional regulatory strategies in support of the global development plan using relevant competitor intelligence and therapeutic area knowledge
• Drive the target label and submission based on an understanding of the regional regulatory and cross-functional needs.

Organization and Talent Development:

• Lead, develop and coach a team of up to 6 regulatory leads and/or regulatory professionals
• Support goals and objectives aligned with the EMEA commercial organization.
• Conduct resource management planning for your area of focus,

Liaison with Regulatory Agencies:

• Establish strong working relationships with regulators to lead effective interactions on clinical study design, submissions content, labeling, and post-approval commitments; act as primary contact with EMEA
• Ensure issues raised by Regulatory Agencies are promptly and adequately addressed; ensure implementation of Regulatory Agency comments into the clinical development plan

Input in document and process development:

• Craft comprehensive briefing documents, pediatric investigational plans, orphan drug designations, and summary and response documents to bolster regional strategy and achieve target label.
• Assist in the development of processes related to regulatory submissions
• Provide regulatory input to critical submission documents throughout the product lifecycle across your disease area.

Clinical Trial Applications (CTA):

• Ensure protocols support registration, reimbursement, and differentiated labeling
• Guide cross-functional team on EMEA CTA requirements
• Ensure CTA submissions are complete and available according to timelines

Marketing Authorization Application:

• Provide regulatory leadership throughout registration process and post-approval
• Manage submissions, define submission plans, and advise on required documents and strategies for MAAs
• Ensure timely MAA availability; track critical path activities
• Ensure country-specific submission packages are prepared for LOCs per plans

Qualifications:

Education and experience:

• Masters' degree in life sciences or equivalent experience
• Extensive and broad EU regulatory experience (10+ years) in drug development and commercialization across multiple therapeutic areas, phases, and countries

Skills:

• Influencing and conflict resolution skills
• Excellent oral & written communication skills
• Organization, prioritization, project management & multi-tasking skills
• Strategic insight and innovative thinking
• Ability to stay updated on regional regulatory developments and assess business impact
• People management and coaching skills

Knowledge:

• Excellent knowledge of English
• Knowledge of the applicable therapeutic area

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium and The Netherlands: Requisition Number: R-013246

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.