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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 and act as primary contact with EMEA

• Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed and ensure implementation of Regulatory Agency comments into the clinical development plan

Input in document and process development

• Play a key role in crafting comprehensive briefing documents, pediatric investigational plans, orphan drug designations, and summary and response documents to bolster our regional strategy and achieve our 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 requirement

• Ensure CTA submissions complete and available according to agreed timelines

Marketing Authorization Application

• Provide regulatory leadership throughout registration process and post-approval

• Manage submissions, define submission plans, and provide inputs to team on required documents and submission strategies in preparation of MAAs.

• Ensure timely MAA availability, track critical path activities

• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed 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 (for example, experience in multiple therapeutic areas, multiple phases of drug development, multiple countries)

Skills

• Influencing and conflict resolution skills

• Oral & written communication skills

• Organization, prioritizing, project management & multi-tasking skills

• Demonstration of long-term strategic insight and innovative thinking

• Ability to keep abreast of regulatory developments in the region 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.