Global Regulatory Strategic Leader

Há 2 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$400.000 - R$450.000
Job Opportunity:

This leadership position oversees the planning and execution of regulatory strategies for assigned products across Brazil, Argentina, and Colombia. The successful candidate must have expertise in regulatory affairs, product development, and regulatory approvals.Main Responsibilities:
  • Align local regulatory requirements with corporate standards
  • Provide local input to and complete regulatory strategies
  • Plan and handle local regulatory submissions in compliance with corporate standards and local regulatory requirements
  • Guide local mechanisms to optimize product development and regulatory approvals
  • Ensure local labels are developed and maintained in line with local legislation and procedures
  • Ensure and support local regulatory product compliance
Key Activities:
  • Develop and implement filing plans for market authorization and lifecycle maintenance
  • Lead regulatory submissions on time and meet corporate and local regulatory requirements
  • Create, review, and approve source text for country labeling, and lead country artwork based on source text
  • Collaborate with regional and global teams to support local planning and execution for clinical studies
  • Review and approve promotional and non-promotional materials
  • Maintain awareness of new and developing legislation, regulatory policy, and technical guidance relating to products
Requirements:
  • Knowledge of regulatory principles
  • Working with policies, procedures, and standard operating procedures
  • Comprehensive understanding of regulatory activities and their effects on other projects and processes
About this Role:

We are seeking a highly skilled professional to join our team as a Regulatory Affairs Director. The ideal candidate will have a strong background in regulatory affairs, product development, and regulatory approvals. This is an excellent opportunity for a motivated individual to take on a leadership role and contribute to the success of our organization.

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