Sr. Manager, CMC Regulatory Affairs

2 settimane fa

parma, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

Select how often (in days) to receive an alert: Business Area: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Remote, US Chiesi USA Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 7,000 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, inclusion, and equal opportunity 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. Who we are looking for Purpose 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. Main Responsibilities 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

  • Sr. Manager, Cmc Regulatory Affairs

    1 settimana fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Select how often (in days) to receive an alert:Business Area: R&D, Pharmacovigilance & Regulatory AffairsContract Type: PermanentLocation: Remote, USChiesi USABased in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in 31 countries.More than 7,000 employees across the group are united by...

  • EU Regulatory Affairs Manager, Rare Diseases

    4 settimane fa

    Parma, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

    EU Regulatory Affairs Manager, Rare Diseases Date: 8 Oct 2025 Department: GRD Regulatory Affairs Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years'...

  • Regulatory Affairs Specialist

    2 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Department**: International Markets Development Division **Job Type**: Direct Employee **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Contract Type**: Permanent **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in...

  • Eu Regulatory Affairs Manager, Rare Diseases

    3 giorni fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    A leading pharmaceutical company in Parma is looking for a Regulatory Affairs professional.The role includes developing regulatory strategies for Emerging Markets and managing regulatory submissions.Candidates should have 3 to 5 years of experience in corporate regulatory affairs and hold a Life Science Degree.The company values its employees, offering...

  • EU Regulatory Affairs Manager, Rare Diseases

    4 giorni fa

    parma, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

    A leading pharmaceutical company in Parma is looking for a Regulatory Affairs professional. The role includes developing regulatory strategies for Emerging Markets and managing regulatory submissions. Candidates should have 3 to 5 years of experience in corporate regulatory affairs and hold a Life Science Degree. The company values its employees, offering...

  • Regulatory Affairs Project Manager

    21 ore fa

    Parma, Italia JSB SOLUTIONS S.R.L A tempo pieno

    **JSB Solutions**, azienda nata nel 2009 con 3 sedi in Italia (Firenze, Parma e Milano) operante nel settore Life Science e che offre servizi di consulenza, servizi CRO e soluzioni software per le aziende farmaceutiche, biotecnologiche e industriali è alla ricerca di un **Regulatory Affairs Project Manager **_(Rif.SRF 22.032)_. - Coordinamento e definizione...

  • Eu Regulatory Affairs Manager, Rare Diseases

    5 giorni fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    EU Regulatory Affairs Manager, Rare DiseasesDate: 8 Oct ****Department: GRD Regulatory AffairsBusiness Area: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years' experience,...

  • Global Regulatory Affairs Manager

    1 settimana fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**:16 Dec 2024 **Department**:Global Regulatory Affairs **Team**:R&D, Pharmacovigilance & Regulatory Affairs **Job Type**:Direct Employee **Contract Type**:Permanent **Location**:Parma, IT **_About us_** - Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience,...

  • EU Regulatory Affairs Manager, Rare Diseases

    6 giorni fa

    parma, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

    EU Regulatory Affairs Manager, Rare DiseasesDate: 8 Oct 2025Department: GRD Regulatory AffairsBusiness Area: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience,...

  • Eu Regulatory Affairs Manager, Rare Diseases

    2 giorni fa

    Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Department: GRD Regulatory Affairs Business Area: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout usBased 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...