Johnson & Johnson Careers

Senior Director EMEA Regulatory AffairsTherapeutic Area Leader Haematology / Oncology

High Wycombe, United Kingdom; Leiden, Netherlands; Beerse, Belgium
Regulatory Affairs


Job Description

Requisition ID: 00001B

EMEA Regulatory Affairs is looking for a candidate for the position of EMEA Therapeutic Area Leader for the Haematology / Oncology Portfolio.  This portfolio includes products to treat various types of diseases within Haematology and Oncology, at different stages of the product life cycle, from very early phase into late life cycle. The current portfolio represents a highly significant part of the Janssen EMEA portfolio in terms of commercial value, growth opportunities and R&D investment.

 
Principle Responsibilities include:

Regulatory Strategy

  • Oversee all activities for the Haem/Onc portfolio within the region using strong time and project management skills.
  • Shape the regional regulatory strategy for the organization through a deep understanding of the regulatory environment, commercial relevance, supply chain, and organization. Primary focus is the EU but strategy must also pertain to other EMEA countries including Emerging Markets.
  • Provide oversight and guidance on implementation of regional regulatory strategy.
  • Ensure alignment of regional regulatory strategy with global regulatory strategy.
  • Ratify submission strategy and strategy for Regulatory Agency interactions for the region based on a strong understanding of region-specific guidelines for submissions and interactions with Regulatory Agencies.
 

Liaison with Regulatory Agencies

  • Manage relationships with key European and national Regulatory Agency leaders and influence the regulatory environment.
  • Ensure that company personnel are prepared for interactions with Regulatory Agencies.
 

Liaison with Local Operating Companies

  • Liaise with Head of LOCs (clusters) to align strategy and execution of Regulatory Agency interactions.
 

Input in compliant document and process development

  • Effectively set direction and establish priorities for the region to ensure compliant, efficient and effective operation of regulatory processes within the region.
  • Review and provide input to critical submission documents, including labeling, to ensure they thoroughly and accurately support the regional regulatory strategy.
Team Management.
  • Provide clear oversight and guidance to EMEA Regulatory Liaisons to ensure timely execution of activities and enhance their professional development; organize team accordingly.
  • Provide line management, coaching, and guidance to Regulatory Liaisons and Regulatory Scientists.
  • Conduct financial and resource management planning for the TA.
  • Work with other Regional Therapeutic Area Leaders on sharing of resources to address fluctuations in workload. 


Qualifications
  • A minimum of an advanced University degree (MSc, PhD, PharmD) in life-sciences is desired. 
  • Breadth of regulatory experience in drug development and life-cycle management.
  • Experience in multiple type of products and multiple therapeutic areas is desired. Appropriate experience in the Haem/Onc TA is strongly preferred
  • In-depth knowledge of the regulatory environment, guidelines and practice of the EMEA region is required. 
  • Experience with relevant EU regulatory procedures; appropriate understanding of non-EU territories is preferred.
  • Experience in working in global multi-disciplinary teams with strong R&D and Commercial engagement. Experience in working with development/licensing partners is preferred.
  • People management skills in a virtual environment, complex project management skills and excellent oral & written communication skills, as well as experience working in a matrix organization will be needed.
  • Excellent English verbal and written communication skills are required.
 

The position is preferably based in one of the EMEA-RA TA-offices (High Wycombe (UK), Leiden (NL), Beerse (BE)).



Primary Location
United Kingdom-England-High Wycombe-
Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
00001B