Senior, CMC Regulatory Affairs Manager (Gene Therapy)
6 days left
- Experience Level
Be part of a Fondazione Telethon/San-Raffaele Telethon Institute for gene therapy leading academic organization.
The position may be remote based in Italy (Milan), or a mixture of office and remote based.
As a Senior Manager in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of ex-vivo and in-vivo gene therapy within the Alliance Management & Regulatory Affairs Group which forms part of our Research & Development Division.
The Unit is growing and there are excellent prospects for professional development and enhancing your skills. With a variety of new gene addition and gene editing projects, we are looking to enhance the knowledge within our team with the addition of this hire. Activities encompass translational early and late stage drug development, with insight into marketing registration and product maintenance.
We are seeking individuals with experience in technical development, testing and manufacturing of gene therapy medicinal products (GTMP). In particular, with cell and gene therapies in-depth experience in one of the following areas: analytical testing and characterization, control strategies, cell culture, vector production, process design/development, starting/raw materials quality criteria definition, stem cells/linfoT-based GT development.
Provides a range of regulatory writing services with supervision of senior team members to a high quality and on time delivery
We are seeking individuals who provides a range of regulatory writing services with supervision of senior team members to a high quality and on time delivery. You’re expected to work independently and on more complex projects.
- Proven global regulatory experience in the area of cell and gene therapy is a pre-requisite.
- Serve as a technical expert in development, testing and manufacturing of gene therapy medicinal products (GTMP) and resource to SR-TIGET colleagues, and Telethon/OSR providing advice.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams. Provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Actively anticipate and develop initial or alternative EU/US regulatory strategies, consulting with other resources within the organization as required.
- Lead and/or participate in the review of CDMO quotations and service agreement negotiations for projects commissioned to third specialized parties.
- Effectively manage the preparation of CMC regulatory submission documents (IMPD/IND, other relevant briefing packages) including National GMO authorizations.
- Facilitate CMC IMPD/IND submission, approvals and amendments through leading communications and negotiations with regulatory agencies and project teams as necessary, directly and indirectly.
- Provide the project teams with strategic advice in response to regulatory agencie’s queries, based on regulatory experience and area of expertise.
- Provide the project teams with advice in comparability exercises as required depending on the strategy.
- Enthusiastically monitors for new regulatory requirements and shares key findings.
The ideal candidate has attention to detail, positive team relationships with colleagues, good communication, organizational and analytical skills.
- Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field.
- Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.
- 4+ years pharmaceutical gene therapy Regulatory CMC experience in the global environment (e.g. Europe and US) including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance) - international experience preferred.
- Experience with pharmaceutical development of gene therapies products, analytical characterization, process scale-up, stability and/or GT regulatory registration of products is required.
- Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.
- Experience supporting business development activities management an asset.
- Demonstrates leadership, problem-solving ability, flexibility and values teamwork.
- Demonstrated ability to work well within a matrix structure in a complex environment.
- Exercises good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
- Excellent written and oral communication skills required.
- Active participation in Agency/Industry groups/forums preferred.
- Certification in regulatory affairs (RAC) or post-secondary institution beneficial.
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