Regulatory Affairs Professional

Há 5 dias

São Paulo, São Paulo, Brasil beBeeRegulatoryAffairs Tempo inteiro R$90.000 - R$120.000

At the forefront of neuroscience, our mission is to defeat devastating neurological diseases through innovative scientific research. As a key member of our Regulatory Affairs team, you will play a vital role in ensuring timely business support by driving the creation and submission of high-quality dossiers for new medicines. This includes elaborating on local sanitary dispositions, handling queries from regulatory authorities, and following up on the progress of these submissions.

Key Responsibilities
  • Develop comprehensive dossiers for new synthetic and biological medicines based on local regulatory requirements.
  • Engage with regulatory authorities to address queries and resolve any issues related to dossier evaluation.
  • Monitor and track the status of ongoing submissions and respond to queries raised by regulatory bodies.
  • Evaluate the impact of new regulations and public consultations on our business operations.
  • Stay informed about competitors' product registrations and market developments.
  • Represent our organization at industry association meetings to discuss regulatory updates and best practices.
  • Review and approve promotional materials to ensure compliance with regulatory standards.
Requirements
  • Bachelor's degree in Pharmacy or Biochemistry.
  • Fluency in English.
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint).
  • Minimum 5-6 years of experience in Regulatory Affairs.
  • Previous experience in reviewing promotional materials is essential.
  • Detailed knowledge of local sanitary dispositions for synthetic products.
  • Experience with International Federation of Associations of Pharmaceutical Physicians (IFAPP) is mandatory.
  • Familiarity with API legislation and Biosimilar regulations is highly desirable.

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