Director EMEA Regulatory Leader – Solid Tumor Oncology
Join to apply for the Director EMEA Regulatory Leader – Solid Tumor Oncology role at Johnson & Johnson
Director EMEA Regulatory Leader – Solid Tumor Oncology
4 days ago Be among the first 25 applicants
Join to apply for the Director EMEA Regulatory Leader – Solid Tumor Oncology role at Johnson & Johnson
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:
Beerse, Antwerp, Belgium, Leiden, Netherlands
Job Description:
About Johnson & Johnson
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.
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):
United Kingdom: Requisition Number: R-014347
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Hospitals and Health Care
Referrals increase your chances of interviewing at Johnson & Johnson by 2x
Get notified about new Legal Director jobs in Beerse, Flemish Region, Belgium.
Antwerp, Flemish Region, Belgium 3 weeks ago
Antwerp, Flemish Region, Belgium 2 days ago
Antwerp, Flemish Region, Belgium 1 week ago
Antwerp, Flemish Region, Belgium 5 months ago
Kontich, Flemish Region, Belgium 2 hours ago
Antwerp, Flemish Region, Belgium 2 weeks ago
Arendonk, Flemish Region, Belgium 1 month ago
Oosterhout, North Brabant, Netherlands 1 month ago
Breda, North Brabant, Netherlands 3 weeks ago
Antwerp, Flemish Region, Belgium 1 week ago
Antwerp, Flemish Region, Belgium 1 week ago
Antwerp, Flemish Region, Belgium 1 week ago
Antwerp, Flemish Region, Belgium 6 days ago
Antwerp, Flemish Region, Belgium 6 days ago
Antwerp, Flemish Region, Belgium 1 week ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr