Locations : EMEA or Dubai
Senior Director level – Pay Grade 41
The position provides regulatory leadership for HMD (DS, CSS, Ethicon) for all EMEA emerging markets (ME, Africa, Russia, Central Eastern Europe), will integrate RALI markets into the structure (70 countries)
- Assures timely regulatory clearances and registrations in EMEA emerging markets for new product launches, renewals to ensure timely market access, continuous product availability and compliance.
- Serve as the RA leader on the EMEA emerging markets LT, provide strategic direction by establishing and implementing strategic and operational plans for EMEA emerging markets considering global Franchise and reginal business strategies and needs
- Monitor, assess and impact the vastly developing emerging market regulatory environment, establish strategies and ensure compliant implementation into regional processes and communication to global functions and regional business.
- Integrate RALI, build an organization with right talent and capabilities. Inspires, motivate team and communicate business needs, company and functions vision to team. Is organizationally forward-looking, makes staffing decisions and determines direction to take to achieve global and regional business and policy objectives. Leads and develops the team to ensure solid succession planning and competencies required for the changing regulatory environment.
- Leads and develops the RA planning and servicing team to ensure a high performance and continuous improvement culture, driving efficiencies gains by planning, standardization and continuously challenging the status quo.
- Serve as the key leader on EMEA Emerging Markets on the global RA team, provide input into Franchises.
- Lead the team to understand and plan for new regulations in Russia and other emerging regulations and work with the central RA team to resource and plan for a compliant execution. Ensure compliance by meeting remediation milestones and bring needs to franchise and the central team.
- Partner with regulatory affairs policy to understand, impact and implement new regulatory requirements.
- Ensures that company policies, procedures and practices follow global policies and regional requirements.
- Represents J&J HMD and strategies in external forums such as IMDRF, global, regional trade associations and in authority meetings.
- Identify and implement streamlined regulatory processes and direct the team to deliver robust regulatory strategies required to obtain and sustain market access in EMEA emerging markets.
- Optimize Regulatory resources and drive operational efficiency across EMEA and linked to franchises by ensuring a harmonized approach across the franchises and taking ownership of centralized responsibilities such as RA planning and Supply Chain initiatives.
- Lead, build, and develop a team of Regulatory professionals across multiple locations to ensure strong talent pipeline
- Build strong and trusting relationship with Regulatory leaders in the Franchises and Regions and with cross-functional leaders.
- Develop and oversee EMEA emerging market department budget
- Minimum of a B.A./B.S. is required. M.S., J.D., Ph.D. or M.D. is a plus.
- Minimum of 10 years relevant, medical devices regulatory affairs experience is required. Previous experience with hospital medical devices is highly preferred.
- A minimum of 5 years of people management experience is required. Experience managing distributed, multi-national teams is preferred.
- Senior leadership experience is required, including line management of multiple levels of reporting.
- Demonstrated success in partnering and influencing across a matrix environment is required.
- Demonstrated track record of formulating and executing regional regulatory strategies in support of strategic business objectives is required.
- Previous experience with advanced technologies i.e. digital and or Robotics is plus
- The ability to leverage relations with key constituents to deliver tangible results and clinical insights is required.
- Demonstrated effective change leadership and change management skills are required.
- Professional attitude and service orientation; superb team player
- The ability to actively develop talent and culture to achieve results is required.
- Experience working with professional and trade associations is a plus.
- Languages: English required, any other regional language is a plus
Europe/Middle East/Africa, Europe/Middle East/Africa-United Arab Emirates-Dubai-Dubai
Johnson & Johnson Medical BV (7260)