Pharmaceutical Regulatory Specialist

1 dia atrás

Rio de Janeiro, Rio de Janeiro, Brasil beBeeDiversity Tempo inteiro R$90.000 - R$123.000
Regulatory Affairs Analyst Role

As a key member of our Regulatory Affairs team in Rio de Janeiro, Brazil, you will play a vital role in supporting the management of regulatory priorities and assessments.

Key Responsibilities:
  • Support the management in orienting, training, and supervising analysts and trainees in the CRA team and members from the Hub dedicated to BRA activities.
  • Collaborate with local and regional regulatory teams to establish regulatory priorities and assessments.
  • Represent the management as a regulatory focal point, providing support to areas with regulatory intelligence.
  • Maintain awareness of and disseminate regulatory legislations.
  • Prepare and submit regulatory documents to authorities according to legal and internal deadlines.
  • Develop regulatory strategies and implementation plans for new products.
  • Implement and update the corporate regulatory information management system (Veeva).
  • Provide regulatory assessment of change controls, packaging materials, and labels.
  • Elaborate and submit product information for new products.
  • Monitor product information of competitors and reference medicines for generics and branded generics.
Qualifications and Skills:
  • Graduation in Pharmacy and Post-Graduation.
  • Deep knowledge of Brazilian pharmaceutical legislation, relevant guidelines, procedures, and requirements.
  • Experience in Clinical Research, Pharmacovigilance, Production, Quality Assurance, Research and Development is an advantage.
  • Extensive experience in Health Authority and Trade Associations interactions.
  • Fluent oral and written English.
  • Intermediate Spanish is an advantage.
What We Offer:

We value diversity and believe it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfill your ambitions. Our diverse businesses offer various career moves to seek new horizons.

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