Regulatory Affairs Specialist

Há 4 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$45.000 - R$67.500
Job Title: Regulatory Affairs Specialist

We are seeking a skilled Regulatory Affairs Specialist to join our team. The successful candidate will play a key role in ensuring the maintenance and registration of products in Brazil.

The primary goal is to keep all products available for sale, while adhering to legislation, global and local policies, and strategic planning deadlines set by the company.

You will independently perform Regulatory activities related to less complex submissions, such as package insert and label updates, register renewal, and minor variations. This includes:

  • Requesting applicable documents from Global/Area
  • Reviewing and evaluating provided documentation
  • Translating applicable documents, if necessary
  • Preparing the dossier in accordance with Brazilian regulation and SOP/policies

Under guidance and supervision from your immediate supervisor, you will also perform regulatory activities related to intermediate and greater complexity submissions, including:

  • Registering new products
  • Handling moderate and major variations
  • Initial requests/renewals of Good Manufacturing Practice certificates

As a key member of the team, you will support client areas by providing information on product documentation and other regulatory data. You will also follow discussions of regulations related to products under health surveillance, verifying changes and suggesting necessary adjustments according to needs.

Key responsibilities include:

  • Acting as a focal point/expert of less complex Regulatory themes for local/global teams and external audiences
  • Ensuring correct update of systems and spreadsheets with required data throughout all stages of the process
  • Reviewing and approving promotion and non-promotional materials for products

Qualifications:

  • Higher education in health (Pharmacy-Biochemistry, Biomedicine, Biology)
  • Advanced/Fluent English (reading and writing)
  • Knowledge of Medical Device regulatory regulation and Medicines regulatory regulation
  • Experience as a Regulatory Affairs Analyst

This role offers opportunities for growth and development, working in a collaborative environment with a dynamic team.

Benefits: Competitive salary, comprehensive benefits package, and opportunities for professional growth and development.

What We Offer: A chance to work with a talented team, contribute to the success of the organization, and develop your skills and expertise.

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