Senior Manager, Cmc Regulatory Affairs, Global Rare Diseases

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ppSenior Manager, CMC Regulatory Affairs, Global Rare Diseases Chiesi Parma, Emilia-Romagna, IT /p h3About us /h3 pChiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy.br/Scopra se questa opportunità è adatta a lei leggendo tutte le informazioni riportate di seguito.br/More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet.br/This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.br/Discover more here.At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.br/This fosters a culture of reliability, transparency, and ethical behaviour at every level.br/As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.br/Diversity and inclusion are at the heart of who we are.br/We believe our differences make us stronger.br/We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. /p pChiesi Global Rare Diseases /p 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. This 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. /p pThe unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. /p pDiscover more here. /p h3What we are looking for /h3 pCurrently seeking a Regulatory Affairs (RA) Senior Manager with strong CMC pre and post approval experience to support Chiesi's Global Rare Diseases (GRD) global portfolio of commercial products. /p h3This is what you will do /h3 ul liMaintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities, according to the GRDRA strategy.



/li liManage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team and GCST, with full responsibility and no need of supervision. /li liAct as the GRDRA CMC representative at core team level with a global role, where required. /li liAuthor and/or review CMC sections of the dedicated GRD portfolio for new marketing authorisation applications, investigational applications and variations/supplements, worldwide. /li liAdvise to multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier. /li liReview and assess change control requests pertaining to CMC aspects of GRD product(s). /liliIn alignment with GRDRA CMC functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy for the GRD products life cycle and development. /li liMaintain submission information according to the document management system, track regulatory CMC commitments timelines for specific projects/products/markets with minimal supervision. /li liWork collaboratively with external CMOs and cross‑functional teams on projects like process optimisations, scale up and technology transfer activities. /li liIn agreement with GRDRA CMC functions and collaborating with GRDRA region functions, negotiate with regulatory agencies strategies and actions on CMC sections of submission dossier. /li liSupport the development of processes and to the preparation of Standard Operating Procedures where required. /li liSupport due diligence activities on CMC regulatory documents, where required. /li liRepresent GRDRA during GMP inspections by regulatory agencies, where required. /li liMaintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements. /li /ul h3You will need to have /h3 ul liMinimum of a bachelor's degree in a Scientific or Technical Discipline; Advanced Degree strongly preferred.



/li li7 + years of Regulatory CMC experience; 3 + years experience in Biologics/Biopharmaceuticals (candidates without Biologics experience will not be considered). /li liAdvanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements. /li liSound knowledge of manufacturing technical transfer and comparability regulatory requirements. /li liExperience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations. /li liProficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system. /li liStrong attention to detail. /li liAbility to multi-task, stay organised and prioritise. /li liStrong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems. /li liAbility to work independently and in a group setting and thrive in a fast‑paced environment. /li /ul h3Location /h3 pThe role can be based in one of our affiliates in Europe. /p h3Compensation (package applied for role based in Italy) /h3 pThe minimum salary for this role is 59.040. /p pThe final offer will reflect the candidate's skills, experience, qualifications and internal equity considerations. /p pThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance. /p h3Benefits /h3 ul lipension /li liprivate medical insurance /li liwellbeing programme /li liflexible benefits programme /li /ul pThe package outlined above is based on the role being located in Italy. /p pWhere the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. /p pFull details of the applicable package will be provided at the appropriate stage of the recruitment process. /p h3What we offer /h3 pNo matter where your path starts at Chiesi, it leads to inspiring possibilities. /p pYour future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. /p pWe provide top‑class benefits, including comprehensive healthcare programmes, work‑life balance initiatives, and robust relocation support. /p pOur salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. /p /p #J-18808-Ljbffr

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