Senior Manager, CMC Regulatory Affairs, Global Rare Diseases
Parma, Emilia-Romagna, Italy · Remote OK
$59k/yr
Senior
About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the grou…
Skills: CMC Regulatory Affairs, Biologics, Biopharmaceuticals, CTD M2 and M3 Authoring, Life Cycle Management
Chiesi Corporate Functions Global Human Resources The HR Team welcomes and guides people through every step of their journey, supporting the creation of space for personal fulfillment and professional growth. The Global …
Skills: Learning Management System, SharePoint, Data Analysis, Digital Content Creation, Stakeholder Management
About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the grou…
About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the grou…
Skills: Clinical Operations Leadership, Global Drug Development, Clinical Development Plan (CDP), Vendor & CRO Management, Budget Oversight
Manager, Americas Regulatory Affairs Labeling & Promotion, Global Rare Diseases
Boston, Massachusetts, United States · Remote OK
$121k–$182k/yr
Senior
About Us Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singula…
Sr. Director, Real World Evidence, Global Rare Diseases
Boston, Massachusetts, United States · Hybrid
$223k–$335k/yr
Senior+
About Us Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singula…
Skills: Real World Evidence, HEOR, Epidemiology, Strategic leadership, Integrated Evidence Generation Plans
Manager, Americas Regulatory Affairs Labeling & Promotion, Global Rare Diseases
Boston, Massachusetts, United States · Hybrid
Senior+
About Us Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singula…
Manager People Development / Team Coach (all genders)
Hamburg, Germany · Hybrid
Senior
Über uns Chiesi verfolgt die Mission, die Lebensqualität der Menschen zu verbessern und dabei verantwortungsvoll gegenüber Gesellschaft und Umwelt zu handeln. Als forschungsorientiertes, biopharmazeutisches Unternehmen e…
Skills: Personnel Development, Team Coaching, Organizational Development, Training Design, Workshop Facilitation
GCP specialist R&D Auditing Department - Temporary
Parma, Emilia-Romagna, Italy · Hybrid
$39k/yr
Entry level
About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the grou…
Portfolio Operations & Launch Excellence Manager, International Markets Development Division
Parma, Emilia-Romagna, Italy · Hybrid
$59k/yr
Senior
About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the grou…
Medical Information & PV Officer Chiesi is seeking a Medical Information & Pharmacovigilance Officer to join our Pharmaceutical Affairs team. This role offers a great opportunity for graduates with a healthcare backgroun…
Skills: Pharmacovigilance, Medical Information, Customer Service, Regulatory Compliance, Safety Reporting
About us We are a multinational pharmaceutical company with more than 80 years of experience, offering innovative solutions to improve people's quality of life. Our headquarters are in Parma (Italy), we operate in 26 cou…
Skills: Medical Strategy, Team Leadership, Evidence Generation, Market Access, Patient Advocacy
About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the grou…
Skills: Project Management, Clinical Operations, Real World Evidence, Study Design, Budget Planning
Isso é o que você fará O Analista de Planejamento de Produção Sênior desempenha um papel fundamental na garantia da eficiência e eficácia dos processos de planejamento e produção. Lidera o processo de S&OP, coordenando a…
Skills: Production Planning, Sales and Operations Planning, Inventory Management, Forecasting, ERP Systems
Medical Science Liaison, Global Rare Diseases - Midwest
Chicago, Illinois, United States · Remote OK
$142k–$174k/yr
Mid level
About Us Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singula…
Skills: Scientific Exchange, Clinical Research, Medical Education, Key Opinion Leader Engagement, Healthcare Professional Support
Key Account Manager, Global Rare Diseases - Northeast
New York, New York, United States · Remote OK
$161k–$197k/yr
Senior+
About Us Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singula…
Isso é o que você fará O Supervisor de Manutenção tem como atribuições principais assegurar à disponibilidade e confiabilidade dos ativos, através da elaboração, revisão e controle dos planos de manutenção preventiva, id…
About us We are a multinational pharmaceutical company with more than 80 years of experience, offering innovative solutions to improve people's quality of life. Our headquarters are in Parma (Italy), we operate in 26 cou…
Skills: Quality Management Systems, Complaint Management, Technical Documentation, CAPA, Medical Information Management
About us We are a multinational pharmaceutical company with more than 80 years of experience, offering innovative solutions to improve people's quality of life. Our headquarters are in Parma (Italy), we operate in 26 cou…
Skills: Scientific Communication, Clinical Research, Data Analysis, Microsoft Excel, Microsoft PowerPoint
About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the grou…
Responsible for creating and maintaining CMC regulatory documents and strategies for a global portfolio of rare disease products. This includes authoring submission sections, managing change controls, and representing the company during GMP inspections.
Requirements
Requires a bachelor's degree in a scientific discipline with at least 7 years of Regulatory CMC experience, including 3+ years in Biologics. Candidates must possess advanced knowledge of global CMC regulations and proficiency in quality management software like TrackWise.
Full job description
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. 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. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. 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.
Chiesi Global Rare Diseases
Chiesi 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.
Rare 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. Discover more here.
What we are looking for
This is what you will do
Currently 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
You will be responsible for
Maintain 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
Manage 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
Act as the GRDRA CMC representative at core team level with a global role, where required
Author and/or review CMC sections of the dedicated GRD portfolio for new marketing authorisation applications, investigational applications and variations/supplements, worldwide
Advise to multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier
Review and assess change control requests pertaining to CMC aspects of GRD product(s)
In 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
Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision.
Work collaboratively with external CMOs and cross-functional teams on projects like process optimizations, scale up and technology transfer activities.
In agreement with GRDRA CMC functions and collaborating with GRDRA region functions, negotiate with regulatory agencies strategies and actions on CMC sections of submission dossier
Support the development of processes and to the preparation of Standard Operating Procedures where required.
Support due diligence activities on CMC regulatory documents, where required
Represent GRDRA during GMP inspections by regulatory agencies, where required
Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements
You will need to have
Minimum of a bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree strongly preferred.
7 + years of Regulatory CMC experience; 3 + years experience in Biologics/Biopharmaceuticals (candidates without Biologics experience will not be considered)
Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements.
Sound knowledge of manufacturing technical transfer and comparability regulatory requirements
Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations.
Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system
Strong attention to detail
Ability to multi-task, stay organized and prioritize
Strong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems
Ability to work independently and in a group setting and thrive in a fast-paced environment
Location
The role can be based in one of our affiliates in Europe.
Compensation (package applied for role based in Italy)
The minimum salary for this role is €59.040, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.
This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.
In addition, we offer a comprehensive benefits package pension, private medical insurance, wellbeing programme, flexible benefits programme.
The package outlined above is based on the role being located in Italy. Where 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. Full details of the applicable package will be provided at the appropriate stage of the recruitment process.
What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your 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.
We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
Nata a Parma nel 1935 come piccolo laboratorio di provincia, Chiesi pur conservando un forte radicamento in Italia, è oggi un gruppo biofarmaceutico internazionale che conta oltre 6.500 persone, 31 filiali, 7 centri di ricerca, 3 siti produttivi e un fatturato di oltre 2 miliardi di euro.
In oltre 85 anni di storia e tre generazioni, l’azienda ha incentrato le sue attività sulla ricerca, sviluppo, produzione e commercializzazione di soluzioni terapeutiche innovative, sviluppando farmaci di successo distribuiti in oltre 100 Paesi. Le aree terapeutiche principali sono quella respiratoria, neonatologia, medicina specialistica e malattie rare, da sempre ambito di eccellenza del Gruppo.
La nostra missione
Vogliamo essere riconosciuti come Gruppo internazionale incentrato sulla ricerca, in grado di sviluppare e commercializzare soluzioni terapeutiche innovative che migliorino la qualità della vita delle persone.
Intendiamo mantenere un team imprenditoriale di elevata qualità, caratterizzato da spirito di collaborazione e sicurezza in se stesso.
Il nostro obiettivo è unire impegno verso i risultati e integrità, operando con responsabilità sia dal punto di vista sociale, sia da quello ambientale.
Carriera in Chiesi
Chiesi offre numerose opportunità di carriera, in Italia e all'estero, a giovani talenti interessati a lavorare nel farmaceutico. L’obiettivo è selezionare persone meritevoli e di valore e aumentare il loro talento offrendo l’opportunità di esprimere pienamente le proprie energie e potenzialità.
Offices: Via Giacomo Chiesi, Parma, Emilia-Romagna 43122, IT
Nata a Parma nel 1935 come piccolo laboratorio di provincia, Chiesi pur conservando un forte radicamento in Italia, è oggi un gruppo biofarmaceutico internazionale che conta oltre 6.500 persone, 31 filiali, 7 centri di ricerca, 3 siti produttivi e un fatturato di oltre 2 miliardi di euro.
In oltre 85 anni di storia e tre generazioni, l’azienda ha incentrato le sue attività sulla ricerca, sviluppo, produzione e commercializzazione di soluzioni terapeutiche innovative, sviluppando farmaci di successo distribuiti in oltre 100 Paesi. Le aree terapeutiche principali sono quella respiratoria, neonatologia, medicina specialistica e malattie rare, da sempre ambito di eccellenza del Gruppo.
La nostra missione
Vogliamo essere riconosciuti come Gruppo internazionale incentrato sulla ricerca, in grado di sviluppare e commercializzare soluzioni terapeutiche innovative che migliorino la qualità della vita delle persone.
Intendiamo mantenere un team imprenditoriale di elevata qualità, caratterizzato da spirito di collaborazione e sicurezza in se stesso.
Il nostro obiettivo è unire impegno verso i risultati e integrità, operando con responsabilità sia dal punto di vista sociale, sia da quello ambientale.
Carriera in Chiesi
Chiesi offre numerose opportunità di carriera, in Italia e all'estero, a giovani talenti interessati a lavorare nel farmaceutico. L’obiettivo è selezionare persone meritevoli e di valore e aumentare il loro talento offrendo l’opportunità di esprimere pienamente le proprie energie e potenzialità.
Offices: Via Giacomo Chiesi, Parma, Emilia-Romagna 43122, IT