Regulatory Affairs CMC Senior Director

Company: VirtualVocations
Location: Plano
Posted on: September 21, 2023

Job Description:

A company is looking for a Senior Director of CMC-Regulatory Affairs for their gene therapy development programs.
Key Responsibilities:

Develop and implement regulatory CMC strategies for gene therapy programs
Lead discussions with regulatory agencies and prepare high-quality regulatory CMC dossiers
Build and manage a high-performing regulatory CMC team

Required Qualifications:

Bachelor's degree in life sciences or related field
Minimum of 10 years of experience in regulatory affairs or related functions in biotechnology or pharmaceutical industries
Experience in gene therapy CMC
Demonstrated experience leading eCTD formatted submissions
Knowledge of global regulatory guidelines and regulations

Keywords: VirtualVocations, Plano , Regulatory Affairs CMC Senior Director, Executive , Plano, Texas

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