Associate Director / Director, CMC Gene Therapy Regulatory Affairs

Roles and Responsibilities The Associate Director/Director, CMC Gene Therapy Regulatory Affairs is responsible for: Develop innovative CMC regulatory strategies and drive the preparation and submission of high-quality CMC sections of clinical andmarketing applications for gene therapy products Lead interactions with regulatory agencies to resolve CMC issues and foster proactive communication with global regulators Prepare, author, review, coordinate and manage CMC regulatory submissions, including original IND/IMPD, IND/IMPD amendments, annual reports and agency meeting briefing documents in accordance with applicable regulations in timely manner Act as liaison between Regulatory Affairs and other functional areas, such as Technical Operations, Science, and Quality Assurance Represent Regulatory Affairs in cross-functional team meetings Translate regulatory requirements into practical, workable submission plans Review and communicate current and emerging global regulatory requirements for gene therapy products Reports to Senior Director of CMC Regulatory Affairs   Qualifications and Background Requirements The successful candidate must possess a Master's degree in Pharmacy, Biology, Chemistry or related healthcare functional area Ph.D. degree in Science or Engineering is highly desirable Professional Work Experience The candidate must have at least 5 years of regulatory experience in the pharmaceutical or biotechnology industry as it pertains to gene therapy CMC regulatory affairs The candidate must have 3-6 years of experience in gene therapy or biologics manufacturing, process development, process validation, analytical development, or QC The candidate must have a solid understanding of current FDA and international regulations, ICH guidelines, as well as a solid CMC technical background The candidate must have a solid understanding of development of innovative products under standard and accelerated pathways   Travel 0-10%. 1468
Salary Range: NA
Minimum Qualification
Not Specified years

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