Head Global Regulatory IM&S IT-Systems & Strategy
Product Dev SZ
Holzkirchen, Germany
vor 6 Tg.

Job Description

  • Collaborate closely with the Regulatory and IM&S leadership team to facilitate a highly performing IM&S organization which supports global Regulatory Affairs with the optimum efficiency.
  • Develop a Sandoz Regulatory IT strategy with a plan for implementing technologies supporting all current and upcoming authority requirements globally.
  • Support definition, selection and implementation of new IT systems as well as ensuring lifecycle management of existing IT systems in use in Regulatory Affairs.
  • Define the functional KPIs and targets. Determine appropriate actions when targets are not on track and follow up on action plan.
  • Manage the Regulatory budget and resources for Sandoz Regulatory IT projects.
  • Select, recruit, develop, manage, coach, coordinate and appraise the performance of direct / indirect reports and ensure high quality performance management across the Regulatory IT system function.
  • Secure system functionality according to predefined user requirements for the operational management of all regulatory information systems
  • Research trends and requirements within the Regulatory IT landscape and proactively deliver proposals for improvements and digital transformation
  • Foster the use of global RA IT tools across different Regulatory functions to eliminate local and personal tools.
  • Act as a strategic partner for NBS Development IT and serve as business lead in any regulatory IT system project.
  • Lead internal initiatives and represent Sandoz in cooperation with health authorities and industry associations in context with telematics topics such as eCTD, SPOR ISO / IDMP, eAF and electronic portals
  • Define the functional KPIs and targets according to the overall Regulatory objectives. Determine appropriate actions when targets are not on track and follow up on action plan.
  • Minimum requirements

  • University or College Degree in any field or life science, information management or information technology.
  • Broad experience (approx. 10+ years) in the Pharmaceutical area, specifically in Regulatory Operations
  • At least 5 years line management and proven global team leadership experience
  • Strong organizational, planning, resource and international project management skills
  • Advanced leadership skills : Sets clear vision and directions and aligns teams. Motivates and develops to reach out for excellent performance.
  • Inspires to pro-activity and innovation

  • Extensive knowledge in the field of Regulatory guidelines for electronic submission publishing, structured data submissions like XEVMPD and SPOR / IDMP, document management.
  • Organizational awareness, including significant experience working cross-functionally and in global teams.
  • Ability to work independently, under pressure, demonstrating initiative and flexibility
  • High level understanding of Regulatory quality, standards and policies.
  • Ability to mentor, coach associates and to coordinate interactions with internal and external partners.
  • Strong interpersonal and communication skills, and ability to operate effectively in an international environment.
  • Superior people management skills with demonstrated positive leadership, innovative and collaborative behaviors
  • Empathic, powerful, courageous
  • Good communication in English (oral and written)
  • We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives.

    We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers.

    Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.

    Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

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