Regulatory Affairs Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil Novo Nordisk Tempo inteiro
Regulatory Affairs Analyst

About the Role

We are seeking a highly skilled Regulatory Affairs Analyst to join our team at Novo Nordisk. As a Regulatory Affairs Analyst, you will play a critical role in ensuring the safety and efficacy of our products by monitoring the local regulatory environment, compiling and submitting New Drug Application (NDA) and Life Cycle Management (LCM) licences, and developing local labelling.

Key Responsibilities

  • Monitor the local regulatory environment to ensure compliance and support NDA and LCM licence submissions and approvals.
  • Develop local labelling and ensure regulatory compliance in promotional materials.
  • Conduct research on submission requirements and provide information on local regulatory needs to other departments.
  • Draft routine correspondence to regulatory agencies and manage regulatory archiving in accordance with local legislation and SOPs.
  • Collaborate with other departments, including Marketing, Legal, Logistics, and Sales, to maintain open communication and cooperation.
  • Follow RA audits and manufacturing site inspections to ensure regulatory compliance.

Requirements

  • Bachelor's degree in health-related areas, such as Medicine, Pharmacy, Biology, or Biomedicine.
  • Advanced level of English.
  • Experience with regulatory authorities or at an international pharmaceutical manufacturer.
  • Experience in developing labelling materials and reviewing/approving promotional materials, as well as familiarity with regulatory submission processes and requirements.

About the Department

Our Regulatory Affairs department is a collaborative and inclusive team that values knowledge-sharing and innovation. We are committed to creating a culture that celebrates diversity and promotes equal opportunities for all employees.

Working at Novo Nordisk

We are a dynamic company that drives change and innovation in the pharmaceutical industry. We are committed to promoting diversity and inclusion, and we strive to create a work environment that is inclusive and respectful of all employees.

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