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Open nowPosted 123 days ago

Analista Sênior de Assuntos Regulatórios (Med. Biossimilares)

Vertem14 open roles

Where
São Paulo, BR
Work mode
On site
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Your applicationOpen nowAnalista Sênior de Assuntos Regulatórios (Med. Biossimilares)Vertem · São Paulo, BR

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Vertem's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

14.0% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.3%1 day
  2. 4.7%3 days
  3. 14.0%7 days
  4. 22.5%14 days
  5. 38.3%30 days
  6. 59.0%60 days
This job: posted 123 days ago

The posting

A Vertico é uma consultoria de Executive Search que conecta profissionais a oportunidades estratégicas em empresas de destaque no mercado. Estamos conduzindo, em nome de um de nossos clientes, a busca por uma pessoa para o time de Assuntos Regulatórios.

Uma farmacêutica com forte atuação em biológicos e biossimilares busca um(a) Analista Sênior de Assuntos Regulatórios para um time em crescimento, em um ambiente em construção e com autonomia real.

Na prática, você vai participar de todo o ciclo dos dossiês regulatórios, da estratégia à submissão e à aprovação, trabalhando com parceiros internacionais na adaptação da documentação para a ANVISA e com interlocução com agências como ANVISA, FDA e EMA.

O que você vai fazer:

- Preparar e submeter documentos regulatórios para novos registros, alterações e renovações - Contribuir com a estratégia regulatória de medicamentos biológicos, incluindo avaliações de comparabilidade - Acompanhar prazos e entregas regulatórias junto às áreas de P&D e Qualidade - Monitorar mudanças na regulamentação e avaliar seus impactos - Manter a documentação regulatória atualizada

Modelo de Trabalho: Presencial de segunda a quinta, em São Paulo (Cidade Jardim), com sexta-feira em home office

O que buscamos:

- Graduação em Farmácia, Química, Biomedicina ou áreas afins - Experiência com submissões à ANVISA na indústria farmacêutica - Inglês avançado - Diferenciais: experiência com medicamentos biológicos ou biossimilares, contato com FDA e EMA, pós-graduação em Assuntos Regulatórios ou Pesquisa Clínica

Contratação PJ, com possibilidade de CLT

Benefícios: programa de bônus por entrega (submissões e aprovações de dossiês), 13º, férias, plano de saúde, VR, day off de aniversário e TotalPass

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  2. 25 readers review it

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    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Vertem's form

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    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Vertem's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

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  6. The interview in your calendar

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    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
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