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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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