Vp Head Emea Regulatory Affairs Strategy

il y a 2 semaines

Beerse, Flandre, Belgique Johnson & Johnson Temps plein

Johnson & Johnson Innovative Medicines is recruiting for a VP, Regulatory Affairs - Head EMEA Regulatory Affairs Strategy Organization, located in either Beerse, Belgium or a R&D hub-site in Switzerland.


Overview:

The Head EMEA Regulatory Affairs Strategy Organization is a member of the Global Regulatory Affairs organization.

The position resides in the assigned region (EMEA) and is responsible for leading Regulatory Affairs Therapeutic Area activities at the EMEA regional level.


The job holder will build and lead an integrated EMEA Regulatory Affairs Strategy Organization at Janssen, covering all therapeutic areas within the J&J IM Portfolio, including R&D and full life cycle.

The EMEA region comprises Europe, Russia and CIS, Turkey, Israel, Middle East, Africa and West Asia.


The jobholder ensures a high level of regulatory professionalism that meets the standards of contemporary European Regulatory Affairs and other EMEA countries' standards.

The position will drive the long-term growth strategy and vision for regulatory affairs in EMEA.

This entails being a strategic partner to R&D and to the EMEA Commercial organization, as well as partnering with Health Authorities and an active participation in trade associations.


The position is responsible for the management of staff in the Therapeutic Areas of the EMEA region (functional management) and to provide guidance in aligning regulatory affairs in EMEA to ensure synergy and integration among countries within the region and globally.

The role ensures that the organization is optimally run to support the needs of the global/regional regulatory functions such that products are expeditiously and compliantly developed, submitted, and approved within the region.

The position ensures understanding and alignment of global, regional and local goals and objectives.


The position is a
key management position in EMEA, with important influence both in the region and in Global Regulatory Affairs.

The jobholder represents Regulatory Affairs on the EMEA Strategy Leadership Team (ESLT).

The jobholder contributes to key EMEA governance issues including business decisions, yearly Business Planning, Long Range Financial Planning, Integrated Evidence Generation planning, people management, product prioritization, etc.

On behalf of Janssen EMEA Regulatory Affairs, the jobholder is a Member of the Janssen-Cilag International NV (JCI) Board, ensuring compliance with the responsibilities of JCI as the MAH for Centrally approved products in the EU as well as some other, selected products outside EU.

This individual is also a key member of the GRA Regional Regulatory Affairs management team, ensuring cross regional integration with global regulatory strategies and processes.


Key Responsibilities:

Organization and Talent Development:

  • Lead a premier EMEA Regulatory Affairs Therapeutic Area team
  • Provide direction for the activities and operating processes of regulatory affairs in EMEA
  • Align goals and objectives with TAs and EMEA commercial organization; ensure harmonized approach for input into product development, compliance, training, career development, etc.
  • Provide line management, supervision and coaching of regulatory staff in the EMEA Therapeutic Areas
  • Synergize with EMEA Local Operating Companies
  • Ensure Heads of LOCs are aligned with TA head strategy and work with peers to ensure appropriate local execution with regard to Regulatory Agency interactions, including adherence to corporate image
  • Ensure functional networks between global or regional groups operate optimally to ensure appropriate representation of local regulatory requirements and strategy at Regional and Global level
  • Ensure staff are knowledgeable about products and are provided with appropriate technical/therapeutic area training
  • Develop and execute an inclusive talent strategy to ensure optimal talent development, build a pipeline of future regulatory leaders; Support, mentor and foster talent development.
  • Develop and deploy metrics to benchmark performance
  • Ensure development and/or implementation of processes or procedural documentation to support compliance with global and corporate guidelines and policies for regulatory affairs, including identification of gaps and ensuring appropriate training
  • Represent RA in EMEA management groups (ESLT) and contribute to these leadership teams as a competent and skilled business leader
  • Represent Janssen EMEA Regulatory Affairs in the JCI Board, ensuring compliance with the responsibilities of JCI as the MAH for Centrally approved products in the EU as well as some other, selected products outside EU

Regulatory Strategy:

  • Develop, drive and implement the EMEA Regulatory Strategy in alignment with the Global strategy with the objective of longterm growth
  • Provide oversight and guidance on the development and implementation of multinational/regional registration and compliance strategies that optimize development, reg

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