PpBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p h3Location /h3 pEurope - remote / US - remote, IT /p h3About us /h3 pBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: bDiscover more here /b /p pWe are proud to have been awarded with bB Corp Certification /b, a recognition of bhigh social and environmental standards /b. We are a breliable /b company that adopts and promotes a btransparent and ethical behavior /b at all levels. /p pWe believe that the success of bChiesi is built and shaped by our people and our strong set of shared Values and Behaviors /b. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors. /p pWe are committed to bembrace diversity, inclusion and equal opportunities. /b In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. /p h3Chiesi Global Rare Diseases /h3 pChiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. /p pThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. /p pRare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. bDiscover more here /b. /p h3What we are looking for /h3 h3Purpose /h3 pGRD Technical Leader is accountable for the budget, strategy and execution of CMC development and IMP supply of projects within the GRD portfolio from candidate nomination/selection to handover to manufacturing organisation for commercial launch. /p pThe successful candidate is highly experienced in the field of drug development. The candidate appreciates leading an international team of experts where she/he can provide strategic guidance as well as make use of her/his subject matter expertise. Further should the candidate appreciate teamwork and be communication, leadership and social savvy to make the development run as smooth as possible. /p h3Main Responsibilities /h3 ul liBuild the overall strategic development plan in collaboration with product/project Core Team. /li liMeet the project milestones and long term business objectives. /li liDrive execution of the CMC development plan in compliance with the regulatory strategy. /li liLead new business development opportunity evaluations with focus on CMC. /li liBuild and organize an extended technical team by sourcing the right internal and external competences according to project needs. /li liLead and manage external consultants. /li liLead the ETT based on the project scope and strategic development plan. /li liProject budget accountability for CMC activities (CRO’s, CDMOs, main consultancy agreements etc). /li liAct as subject matter expert in areas of competence. /li liReview the ETT workstreams development plans and align it with the overall strategic development plan. /li liLead and manage long term relationships with academic partners/CRO/CDMOs for successful delivery of collaboration and outsourced projects with Chiesi values and shared value in mind. /li /ul h3Experience Required /h3 ul liMinimum 10 years of relevant industrial experience from the pharmaceutical industry. /li liExperience from analytical or process development or manufacturing of drug substances, drug products or medical devices. Experience in the cell and gene therapy/advanced therapeutic and medicinal product field is meriting. Especially round RNA and LNP development and analysis. /li liHighly experienced in working in an international environment leading and managing internal and external activities, resources, and stakeholders. /li liExperience from regulatory interactions with EMA and/or FDA and quality module 3 documentation and requirements. /li liExperience from working with CMOs and CROs. /li /ul h3Education /h3 pMinimum Master of Science in relevant field /p h3Languages /h3 pEnglish - Fluent in verbal and written communication /p h3Technical Skills /h3 ul liGood knowledge regarding GMP compliance and process and method validations. /li liGood knowledge of drug development framework including regulatory guidelines, best practices and industry standards. /li liProject leader skills. /li /ul h3Soft Skills /h3 ul liLeadership and social influence /li liPlanning and organizational skills /li liStrategic thinking /li liProblem solving /li /ul h3What we offer /h3 pYou would join a dynamic, fast-growing, challenging and friendly environment. /p pIn Chiesi we firmly believe that bour people are our most valuable asset /b, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular battention to the quality of our working environment and collective well-being. /b /p pbWe want our people to come to work happy every day, /b and we know how important it is to find the right bwork-life balance /b in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services. /p h3DISCOVER ALL OUR JOB OPPORTUNITIES /h3 /p #J-18808-Ljbffr