Senior Director, Emea Regulatory Affairs Ta Head
Il y a 2 mois
The EMEA Regulatory Affairs Organization within Johnson & Johnson Innovative Medicines is recruiting for a Senior Director EMEA Regulatory Affairs Therapeutic Area Leader Neuroscience/Cardiovascular & Metabolism and Retina, located in either Beerse, BE, High Wycombe, UK or Leiden, NL.
**Overview**:
This position is a key role within the Global Regulatory Affairs organization and resides in the assigned region (EMEA) with responsibility for leading the EMEA Regulatory Affairs Therapeutic Area activities for Neuroscience/Cardiovascular & Metabolism and Retina (NS/CVMR). The EMEA region comprises Europe, Russia and CIS, Turkey, Israel, Middle East, Africa and West Asia. The portfolio includes products to treat various types of diseases within all these therapeutic areas, at different stages of the product life cycle, from very early phase into later life cycle.
The jobholder ensures a high level of regulatory professionalism that meets the standards of contemporary European Regulatory Affairs and other EMEA countries’ standards.
This role will drive the long-term growth strategy and vision for regulatory affairs in EMEA for NS/CVMR portfolio, be a strategic partner to R&D and to the EMEA Commercial organization and will partner with Health Authorities.
The position is responsible for the management of staff in the NS/CVMR EMEA RA Therapeutic Area (functional management), 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 jobholder represents Regulatory Affairs on the NS/CVMR EMEA Therapeutic Area Strategy Team (TAST) and on the Global NS/CVMR Reg affairs leadership teams. 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.
**Key Responsibilities**:
**Organization and Talent Development**:
- Lead a premier EMEA Regulatory Affairs Therapeutic Area team
- Align goals and objectives with NS/CVMR TA 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 NS/CVMR EMEA Therapeutic Area
- Synergize with EMEA Local Operating Companies: Ensure Heads of LOCs are aligned with NS/CVMR TA strategy and work with peers to ensure appropriate local execution with regard to Regulatory Agency interactions, including adherence to corporate image
- Ensure staff are knowledgeable about NS/CVMR portfolio 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.
- Represent RA in EMEA TA Strategy Teams (TAST) and contribute to these leadership teams as a competent and skilled business leader
- Work with GRA compliance groups, as well as with EMEA compliance functions to implement processes, standards and training that ensure a high level of regulatory compliance
- Ensure that systems are in place and staff are trained to track MAH obligations, HA queries, CMC questions, CCDS changes, product approvals, submissions excellence, etc.
- Conduct financial and resource management planning for the TA
**Regulatory Strategy**:
- Develop, drive and implement the EMEA NS/CVMR Regulatory Strategy in alignment with the Global strategy with the objective of long-term growth
- Provide input to critical submission documents throughout the product lifecycle to ensure they support the regional requirements
- Maintain expert knowledge in EMEA regulatory requirements and ensure that staff has required expertise
- Provide guidance to staff in developing options to manage risks and overcome barriers
- Provide input into decision making and processes that impact registration and commercialization of products in EMEA
- Ensure regulatory participation in IBVTs (Integrated Brand Value Teams) and ensure appropriate staffing
- Ensure that Health Authority engagement strategies are defined for proactive and reactive communications
**Health Authority and Key Stakeholder Interactions**:
- Ensure optimal relationships with key EMEA Regulatory Agency leaders; Shape and appropriate influencing of the regulatory stakeholders
- Establish relationships with local Health Authorities and support regional regulatory staff in their relationship and interactions with HAs
- Ensure that staff are provided with appropriate technical/therapeutic area support for HA interactions
- Ensure excellent collaborative relationships with key stakeholders, including commercial,
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