The Modena Site is a young acquisition with state of the art cell factory, certified by AIFA.
The team at site consists of appr.
25 FTE with strong background in cell therapy development.
The site offers options for significant expansion and highly specialized development for iPSC-derived therapies.
To efficiently support ongoing activities and needs in the field of Advanced Therapies Medicinal Products (ATMP), we are looking for a highly motivated ATMP CMC Regulatory Affairs Expert.
ATMP Global Regulatory Affairs (GRA) is an integral part of the Cell Therapy Business Unit, and the ATMP CMC Regulatory Affairs Expert will contribute to company success by taking care of the CMC regulatory matters of gene and cell therapies.
This role is responsible to provide CMC regulatory strategy input for ATMP development projects, both internal, in partnership and customer sponsored.
The role also includes preparation, editing, submission and maintenance of national and international regulatory submissions and maintaining relationship with regulatory agencies with regards to the ATMP for the quality/CMC component.
The ATMP CMC RA Manager as an expert member of the ATMP GRA team is expected, in line reporting to the VP ATMP Global Regulatory Affairs, to contribute to the implementation and grow of the ATMP expertise, know-how and support to both internal and client's ATMP projects.
**Responsibilities**:
- Support the VP ATMP Global Regulatory Affairs in acting as primary CMC regulatory representative internally, with customers, with partners and with regulatory agencies for ATMP projects and provide CMC regulatory support for the ATMP development strategies
- Write and coordinate the preparation and review of CMC regulatory documents related to ATMP drugs, also covering compliance with cells donor procurement requirements, genetic modified organism (GMO) peculiarities and non-CE marked medical devices requisites.
- Facilitate submission approvals and amendments for the CMC component of the above mentioned legal frameworks (ATMP drug legislation / cells & tissues legislation / GMO legislation / non-CE marked medical devices) through leading communications and negotiations with client, government agencies, and project teams
- Actively anticipate and develop initial or alternative EU/US regulatory strategies, consulting with other resources within the organization as required.
- Prepare and participate to/lead regulatory agencies meeting such as (but not limited to) Scientific Advice and Innovation Task Force (ITF) at EMA, or national authorities and INTERACT/pre-IND meetings at FDA for the CMC component
- Maintain constant updating to industry standards, CMC regulatory requirements for ATMP and Donor Cells procurement requirements across the different geographic areas.
- Contribute to the expansion of ATMP solutions pipeline to be offered to clients
- Provide support, as appropriate, to the Quality Unit in the supervision of the cGMP manufacturing activities and related certifications/accreditations
**Requirements**:
- Degree or PhD in Science fields (Pharmaceutical Technology and Chemistry, Pharmacy, Chemistry, Biology, Biotechnology or equivalent).
- At least 5+ years' experience in ATMP Regulatory Affairs, in particular cell-based product.
- Specific experience of CMC ATMP development, translation from research to development, analytical characterization, process scale-up, control strategy and cell banking.
- Proven ability to provide strategic regulatory guidance to drug development support teams.
- Good written and spoken English.
- Effective communication, both verbally and in written form, to customers as well as members of internal teams.
- Experience in preparation of CMC regulatory documents such as Investigational New Drug Applications (INDs)/Investigational Medicinal Product (IMPD) in eCTD
- Ability to effectively manage multiple projects and priorities across different regulatory frameworks
Desirables:
- Knowledge on Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) for pre-market submissions in combination with ATMP drugs development.
- Knowledge on preclinical development.
Based on the employee's professional growth and the training undertaken, the responsibilities may include other tasks and change overtime.