Rocket is seeking an Associate Director/Director Regulatory – CMC to support the success of our AAV and LVV gene therapy programs by serving as the global product leader for CMC regulatory strategy. S/he will proactively manage multiple Regulatory CMC projects by coordinating with both internal and external stakeholders. S/he will formulate and implement global CMC regulatory strategies for the development of gene therapy programs that are in line with global requirements, and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs.
- Work collaboratively with a focus on development and execution of Regulatory-CMC strategies for gene therapy assets.
- Develop, propose, and execute a globally-oriented Regulatory-CMC strategy for a pipeline assets from clinical development to licensure. These submissions will include Health Authority Briefing Packages/IND/IMPD/BLA and MAA regulatory filings.
- Prepare and review CMC submission documents, registration dossiers, and responses to health authorities with other relevant line functions.
- Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
- Take on a leadership responsibilities for gene therapy Regulatory-CMC submissions including interfacing with internal team members, external consultants/CMOs to provide regulatory guidance related to CMC development plans; serving as the Regulatory representative in Health Authority meetings and interacting directly and indirectly with FDA and international Health Authorities for all CMC related issues, as necessary.
- Maintain detailed knowledge of global CMC regulatory requirement and changing environment relevant for gene therapies
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- BA/BS/University degree in Life/Health Sciences required; advanced degree preferred
- Several years’ experience in regulatory CMC and/or viral vector gene therapy technical product development (process, formulation, analytical, quality) preferably in the biotechnology/biopharma industry.
- Experience in interfacing and responding to relevant global regulatory authorities, especially with respect to gene therapy products
- Knowledge and understanding of US and international regulations and ICH guidelines related to CMC gene therapy development
- Experience and knowledge in the preparation of CMC content for major global regulatory submissions including INDs, CTAs, license applications, and meeting briefing packages
- Thrive in a fast‐paced environment combining strategic and tactical capabilities
- Excellent written and verbal communication skills, analytic and problem-solving
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs.
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to firstname.lastname@example.org