• Job Description

  Req#: JR - 115892

  This is where you save and sustain lives

  At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

  Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

  Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

  Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

  Principais Responsabilidades:

  - Apoiar o desenvolvimento, comunicação e implementação de estratégias regulatórias em apoio aos objetivos da equipe e execução do portfólio de produtos;

  - Representar Assuntos Regulatórios em equipes de desenvolvimento multifuncionais;

  - Criar documentação de CMC de alta qualidade, aplicando as estratégias globais de regulamentação do CMC, assegurando conformidade técnica e conformidade normativa, atendendo aos prazos acordados e aos requisitos de publicação eletrônica;

  - Participar de reuniões da equipe de projeto e fornecer orientação normativa relacionada ao CMC para outras áreas, como Manufatura, Qualidade, Controle de Qualidade e Desenvolvimento Técnico;

  - Realizar a pré-avaliação regulatória apropriada dos CRs medida pelo feedback do CMC à RA.

  Requisitos:

  · Superior completo – Farmácia, Bioquímica ou áreas relacionadas à saúde.

  · Inglês Avançado

  · Experiência em indústria farmacêutica e/ou QA/QC, desejável conhecimento em assuntos regulatórios de medicamentos quanto a registro, pós-registro e renovação.

  Horario: Administrativo

  Folgas: Sábados e domingos.

  Reasonable Accommodations

  Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

  Recruitment Fraud Notice
  
  Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

• About the company

  Baxter International Inc. is an American multinational health care company with headquarters in Deerfield, Illinois.

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