ROLE
– Sets up and manages the INT RA subteam comprised of global and country RA roles from countries in scope with the objective of generating optimal registration strategies, ensure their inclusion into global plans and their efficient execution.
– Represents countries in scope of the INT subteam at the global RA subteam level.
– Drives the process of registration plan design, alignment and sign off with relevant regulatory, commercial and DU stakeholders in global, region and countries in all INT markets except for China, Japan and the European Union.
– Maintains up to date contact CO contact lists for programs and COs in scope.
– Partners with global LFs and Regional / country RA roles on regulatory emerging new regulatory policies and requirements and ensures their optimal interpretation and use in project strategies and implementation plans.
– Leads and oversees the implementation of initiatives to enhance efficiency in ways of working and functional excellence.
– Takes a leading role in designing and actioning registration plans for Emerging Markets Brand and acts as main contact point within RA INT for the Emerging Brands Center of Excellence for the portfolio in scope.
– Partners with GRSS&C LCM group on geographic expansion plans and execution for INT countries.
– Partners with RA INT roles and global policy on identification & shaping of policy changes in INT countries.
– Oversees dissemination of information to and education of global roles on INT country/regional requirements.
– Supports the execution of, or acts as a region representative in functional or cross-functional initiatives, particularly those with potential impacts on INT RA resources or FTE allocations.
– Mentors International Program Regulatory Managers and Sr. Managers on ways of working on pipeline management ensuring compliance with NVS quality standards.
– May participate in recruitment of IPRM/D associates and their development.
– May act as deputy of RA Head Pipeline Management, Compliance and Operations.

REQUIREMENTS
– Minimum of 10 years in Regulatory, product development, minimum of 2 years country, regional or global Regulatory.
– Proven track record of HA negotiations, ability to develop and communicate strategic vision.
– Ability to work in cross-functional environment, Proven expertise in project management.
– Highly committed and team oriented, Proven strong leadership skills.
– Proven track record of early recognition of potential regulatory issues, complex situations, sound risk assessment and overcoming hurdles.
– Proven track record of successful risk assessment.
– Ability to travel and represent the organization.
– Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution.