Senior Regulatory Operations Manager

Há 4 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro US$100.000 - US$150.000
Job Title: Senior Regulatory Operations Manager

Job Summary:

As a Senior Regulatory Operations Manager, you will be responsible for managing and delivering regulatory activities for selected studies or multi-protocol programs.

Key Responsibilities:

  • Manage the execution of site activation (including pre-award/bid defense activities) and maintenance for assigned projects in accordance with agreed project timelines.
  • Develop, implement, and maintain management plans according to scope of work and project plans, within agreed project strategies, resolving project-related issues as required.
  • Ensure collaboration across regulatory and site activation teams, including communication with regions and countries, to deliver agreed project scopes in compliance with RSU management plans.
  • Create and review technical and administrative documentation to support business development and enable study initiation and maintenance.
  • Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, while ensuring compliance with regulatory requirements.
  • Guide and oversee multi-regional and multi-protocol programs during initial start-up and maintenance phases as an integral member of the study management team.
  • Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
  • Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
  • Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence to support assigned studies and wider company.
  • Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations, and review/negotiation of contracts and essential documents.
  • Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or maintenance, as applicable).
  • Mentor and coach colleagues as required.
  • Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines, and project plans with project-specific information.

Requirements:

  • Bachelor's Degree in a related field is required.
  • 6 years of clinical research experience, including 3 years in a leadership capacity. Equivalent combination of education, training, and experience.
  • Full knowledge of the drug development process.
  • Full knowledge of applicable regulatory requirements, SOPs, and corporate standards.
  • Strong knowledge of budget management and resourcing.
  • Considerable working knowledge of medical terminology.
  • Strong knowledge of Microsoft Office and email applications.
  • Effective communication, organizational, interpersonal, and leadership skills.
  • Strong negotiation skills.
  • Ability to independently coordinate and manage new processes.
  • Ability to lead and motivate teams.
  • Ability to handle management/personnel issues.
  • Ability to work independently and effectively prioritize tasks.
  • Ability to work well within a matrix team environment.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

About Us:

We are a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.

We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

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