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Open nowPosted 105 days ago

Especialista em Assuntos Regulatórios (Med. Biossimilares)

Vertem13 open roles

Where
São Paulo, BR
Work mode
On site
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Your applicationOpen nowEspecialista em 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

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 105 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 da GlobalX farma, a seleção para a posição de Especialista de Assuntos Regulatórios (Medicamentos Biossimilares/Doenças Raras)

Se você já construiu um dossiê de biológico junto com o parceiro internacional, em vez de apenas receber o material pronto da matriz, essa vaga foi desenhada para o seu perfil.

A GlobalX farma está expandindo a equipe de Assuntos Regulatórios e busca alguém para conduzir submissões de ponta a ponta: da estratégia regulatória de biológicos até a aprovação junto à ANVISA e a autoridades internacionais.

O trabalho é por projetos, com kick-off e autonomia real para direcionar os parceiros internacionais. Boa parte do desafio está na tropicalização: transformar documentação que chega em estágios diferentes de maturidade em um dossiê sólido para o mercado brasileiro. É um ambiente de construção, com mentalidade de startup dentro da indústria farmacêutica, e com exposição direta à diretoria.

Contratação em regime PJ (há também a possibilidade de CLT). Modelo híbrido, com presencial de segunda a quinta e home office às sextas, em São Paulo, região do Cidade Jardim. Pacote inclui plano de saúde e bônus atrelado a entregas.

O que buscamos:

  • Graduação em Farmácia, Química, Biomedicina ou áreas correlatas
  • Experiência em Assuntos Regulatórios na indústria farmacêutica, com atuação em biológicos
  • Domínio dos processos de registro, modificação e renovação junto à ANVISA
  • Inglês fluente para comunicação com autoridades e parceiros internacionais

Desejável: vivência com biossimilares, FDA e EMA, pós-graduação em Assuntos Regulatórios e experiência em tropicalização de dossiês

Contrato PJ diferenciado: 13º, férias, plano de saúde e programa de bônus por entrega (submissão e aprovação de dossiês), VR, Day off de aniversário, TotalPass.

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