Regional Regulatory Practice Area Team Lead

1 month ago

Malvern, United States Cencora Full time

The Regional Regulatory Practice Area (PA) Team Lead (Senior Director) will provide team leadership of regional Practice Area teams for Regulatory Strategy and Procedure Management (SPM) and Regulatory CMC (CMC). They will actively participate in the development and management of the Regulatory Affairs (REG) department within the Value Delivery Centre (VDC) REG, in relation to the SPM and CMC Practice Areas.

The Regional Regulatory (PA) Team Lead is responsible for implementing operational tasks, derived out of global business development effort, including management of large customer projects, in the field of regulatory affairs. They will lead assigned business development and recruitment activities, in collaboration with, and with agreement from, the global REG VDC Head and Practice Area Heads.

Through leadership, The Regional Regulatory (PA) Team Lead will facilitate continued growth in the regional/local REG service domain/business, in collaboration with the Country Manager, RSMs, other regional/local Practice Area team leads (promoting cross-selling) and through appropriate delegation and monitoring execution of expansion within designated priority accounts.


Responsibilities


  • Support marketing and business development activities for regional clients for all existing REG SPM and CMC Services, in collaboration with global REG Practice Area Heads
  • Lead acquisition of new customers (RfP coordination, participation in bid defence meetings)
  • Drive major new regional/local client programmes, including implementation and continuous improvement of budget, KPIs and other project management tasks.
  • Communicate and implement decisions of the REG VDC office within the regional team.
  • Represent departmental interests towards the REG VDC office, including generation, management and reporting on REG country budget, order pipeline and other financial and HR figures
  • Participate in staffing proposals and decisions for projects within the region and ensure utilisation of local/regional resources by collaborating with Practice Area Heads in staffing decisions.
  • Operational steering of the regional Practice Area team.
  • Lead and coach dedicated employees; conduct probation period, annual employee evaluations and goal setting meetings where applicable.
  • Form leadership culture within the team in close cooperation with the country head and with the REG VDC.
  • Represent the company and department towards clients, authorities and associations.
  • Lead the local/regional team to ensure sufficient resourcing across project; consistently implement processes within the region; and continue to develop their ability to deputise/take appropriate self-initiative as the role holder’s job scope diversifies


Qualifications and Preferred Experience


  • Degree in Life Science
  • At least fifteen years of experience in pharmaceutical regulatory affairs.
  • Proven experience in managing cross-functional and cross-country projects, including basic economic knowledge and experience to efficiently and effectively steer the dedicated projects.
  • Proficient leadership qualities, motivational skills and ideally already experienced in leading executives.
  • Capability to coordinate different projects to be executed in parallel.
  • Resilience, willingness to work a flexible schedule and travel.
  • Excellent interpersonal skills
  • Excellent written and verbal communication skills
  • Self-confidence and assertiveness
  • Confidence to work alone as well as in a team
  • Strategic, analytical and structured thinking
  • Ability to assimilate and analyse information rapidly
  • Ability to identify and offer solutions to problems in a pragmatic way
  • Ability to adjust rapidly to new, unknown, challenging situations
  • Fluent in English

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