• , US

Company:  Confidential

Job Title: Sr. Mgr., Global Regulatory Affairs

Job Number: 76181

Location: , US

Job Description

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Responsibilities

* Advise on US FDA procedures and requirements * Maintain collaborative relationship with the Agency * Support preparation and review of regulatory documents. * Ensure timely submissions aligned with Global Regulatory Leads. * Plan and manage regulatory agency interactions. * Collaborate on regulatory strategy and implementation. * Establish and maintain regulatory processes for clinical trials regulatory handling.

Required Skills

* University degree in natural sciences or equivalent, or RAC certification * Minimum 5 years’ experience in Clinical Regulatory Affairs * Extensive experience with Health Authorities. * Basic knowledge of EU/EEA and US regulatory requirements * Experience with regulatory consultants. * Knowledge of clinical trials and pharmaceutical development * Familiarity with therapeutic areas like Cancer and Infectious diseases * Effective communicator and negotiator * Familiarity with regulatory document management systems * Thrives in fast-paced environment, manages multiple products and timelines

Application Deadline: 2024-05-13

 

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