Director EMEA Regulatory Leader – Solid Tumor Oncology

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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 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 submiss...