Regulatory Site Activation Leader

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro

Regulatory Site Activation Manager


Our organization is seeking an experienced Regulatory Site Activation Manager to lead and manage the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This role will oversee the execution of site activation, including pre-award and bid defense activities, as well as develop and implement management plans according to scope of work and project plans.

Key Responsibilities:
  • Oversee site activation and maintenance for assigned projects in accordance with agreed strategies.
  • Develop and implement management plans to ensure successful delivery of project scope.
  • Collaborate with regulatory and site activation teams to deliver project goals.
  • Provide specialist regulatory and technical scientific support to facilitate efficient business development and study initiation.
  • Guide and oversee multi-regional and multi-protocol programs during initial start-up and maintenance phase.
  • Determine regulatory strategy and expectations for submissions and authorizations.
  • Assess and review regulatory landscape and contribute to collection, interpretation, analysis, and dissemination of accurate regulatory intelligence.

Requirements:
  • Bachelor's Degree in a related field required.
  • 6 years clinical research experience, including 3 years leadership capacity experience.
  • Full knowledge of drug development process and applicable regulatory requirements.
  • Strong knowledge of budget management and resourcing.
  • Effective communication, organizational, interpersonal, and leadership skills.
  • Ability to independently coordinate and manage new processes.
  • Ability to lead and motivate teams.

Benefits of this role include:

  • Opportunity to lead and manage high-profile projects.
  • Chance to collaborate with cross-functional teams.
  • Professional growth and development opportunities.

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