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Senior Director Regulatory CMC Gene Therapy

Company: Regulatory Connect
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Senior Director Regulatory CMC Gene Therapy Regulatory Connect are working with a very highly regarded Biotech with a huge development pipe-line of early and late stage products in the Gene therapy space. They are looking for a Head of Regulatory CMC (Senior Director) to lead a product platform team that is responsible for delivering all Regulatory CMC objectives for Gene Therapies.

Great opportunity for someone looking to transition from CMC Biologics to Gene Therapy. Previous Gene Therapy experience is not needed but Biologics is a must.

Requirements:

Leads and manages a team of FTEs, contract staff and vendors to execute the regulatory activities.

Represents Regulatory CMC on platform/project discussions at internal meetings as well as at meetings with regulatory agencies for all CMC related issues.

Provides CMC regulatory guidance for global development and registration programs to junior team members and peers across the organization.

Manages the dossier development process for CMC modules for IND/IMPD/CTA and BLA/NDA/MAA submissions and prepares and review submission-ready CMC and marketing registration applications, supplements, amendments and variations.

Manages and ensures compliance with all reporting requirements, including annual and periodic reports.

Assesses and communicates CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.

Minimum Qualifications:

M.S. required, Ph.D. preferred, in a biomedical discipline with at least 12 years of regulatory experience supporting both development projects and marketed products (or 7+ years Ph.D.).

Prior hands on experience of FDA CMC regulatory submissions is essential with strong knowledge and experience in CMC product development.

Experience in preparing INDs, IMPDs, NDA and/or MAA submission(s) and prior experience in agency engagements and interactions is essential.

Established knowledge of US and international regulatory CMC guidelines and regulations; strong knowledge of eCTD elements and structure and regulatory writing skills.

US Office – We Work 980 6th Ave Bromley, New York NY 10018

Keywords: Regulatory Connect, Cambridge , Senior Director Regulatory CMC Gene Therapy, Other , Cambridge, Massachusetts

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