Remote Senior Regulatory Affairs Manager – Oncology

Syncromune®

Fort Lauderdale (FL)

Híbrido

USD 160 000 - 180 000

Tempo integral

14 dias+

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Vantagens oferecidas por esta oferta de emprego

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Resumo da oferta

A healthcare biotechnology firm is seeking a Senior Manager of Regulatory Affairs to assist with U.S. and international regulatory matters. Responsibilities include preparing regulatory submissions, ensuring compliance, and interacting with regulatory agencies. Candidates must have a Bachelor's degree in Life Sciences or Engineering, plus 5+ years in a regulatory role, ideally in oncology. The position offers a competitive salary of $160,000-180,000 and hybrid work options in Fort Lauderdale, FL.

Qualificações

  • 5+ years in a regulatory capacity at a pharmaceutical company.
  • 2+ years experience supporting oncology products.
  • Ability to translate regulatory requirements into workable plans.

Responsabilidades

  • Support Senior Director to ensure regulatory compliance.
  • Prepare regulatory submissions for new/modified combination products.
  • Interact with regulatory agencies as necessary.

Conhecimentos

Regulatory requirements understanding
Project management
Communication skills
Attention to detail
Analytical skills

Formação académica

Bachelor's Degree in Life Sciences or Engineering
Master's degree preferred

Ferramentas

Microsoft Office Suite
Compliance software

Descrição da oferta de emprego

A healthcare biotechnology firm is seeking a Senior Manager of Regulatory Affairs to assist with U.S. and international regulatory matters. Responsibilities include preparing regulatory submissions, ensuring compliance, and interacting with regulatory agencies. Candidates must have a Bachelor's degree in Life Sciences or Engineering, plus 5+ years in a regulatory role, ideally in oncology. The position offers a competitive salary of $160,000-180,000 and hybrid work options in Fort Lauderdale, FL.
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