Corporate Regulatory Compliance Specialist
2 mesi fa
• Ensure the quality compliance to pharmaceutical standards and to internal procedures;
• Guarantee the regulatory compliance of production and analytical documents and processes to Global registration dossier;
• Provide Global Products life-cycle regulatory support (i.e. CMC documentation review, deficiency letter responses, documentation for first registration);
• Manage Global Products lifecycle quality activities (i.e. item codes attributes on SAP system, materials specifications on LIMS system);
• Support to life-cycle changes assessment and to the implementation phase;
• Bridge activities between manufacturing plants (internal and external) and Global Regulatory Affairs.
At least 4-5 years of experience in Regulatory or Quality Assurance positions in the pharmaceutical industry
EducationDegree in scientific disciplines (CTF, Chemistry, Biology, Pharmacy)
LanguagesFluent English (both written and spoken)
Technical Skills • Knowledge of applicable national and international legislation (EMA, FDA, ICH guidelines, etc.);
• Knowledge of reference pharmacopoeias monographs (EP, USP mainly).;
• Knowledge of GMP and Quality Systems;
• Knowledge of AIFA regulations;
• Knowledge of regulatory framework and registration dossier of MAH.
• Ability to quickly get used to new, dynamic and multicultural working environments;
• Attitude to problem solving and flexibility to find new solutions and alternative routes;
• Organizational skills and time management skills;
• Goal-oriented approach and respect of deadlines;
• Ability to establish good professional collaborations with members of a work group, even under stressfull situations.
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day , and we know how important it is to find the right work-life balance 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.
-
Parma, Italia Chiesi Group A tempo pienoWho we are looking forMain Responsibilities• Ensure the quality compliance to pharmaceutical standards and to internal procedures;• Guarantee the regulatory compliance of production and analytical documents and processes to Global registration dossier;• Provide Global Products life-cycle regulatory support (i.e.CMC documentation review,...
-
Specialist, Labelling
2 mesi fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoSpecialist, Labelling Compliance Regulatory Affairs, Global Rare DiseasesDate: Jul 11, 2024Department: GRD Regulatory AffairsJob Type: Direct EmployeeTeam: RD, Pharmacovigilance Regulatory AffairsContract Type: PermanentLocation: Parma, ITPurposeTo contribute to and oversee GRDRA regulatory information and documentation managed in RIMS and eDMS, and to...
-
Specialist, Labelling
2 mesi fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoSpecialist, Labelling & Compliance Regulatory Affairs, Global Rare DiseasesDate: Jul 11, 2024Department: GRD Regulatory AffairsJob Type: Direct EmployeeTeam: R&D, Pharmacovigilance & Regulatory AffairsContract Type: PermanentLocation: Parma, ITPurposeTo contribute to and oversee GRDRA regulatory information and documentation managed in RIMS and eDMS, and to...
-
Regulatory Affairs Specialist
2 mesi fa
Parma, Italia Bormioli Pharma A tempo pienoThe resource, within Corporate Quality Assurance team, will ensure that a company's products are compliance with national and international regulations: **Main Activities**: - Monitor the developments of regulatory projects applicable to the products and keep up to date with national and international legislation, guidelines and customer practices -...
-
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoWho we are looking for Main Responsibilities • Ensure adherence to pharmaceutical standards and internal protocols; • Safeguard the regulatory integrity of production and analytical documentation and processes in line with Global registration requirements; • Provide comprehensive regulatory support throughout the Global Products life-cycle...
-
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoWho we are looking for Main Responsibilities • Ensure adherence to pharmaceutical quality standards and internal protocols; • Safeguard the regulatory integrity of production and analytical documentation and processes in relation to Global registration submissions; • Provide comprehensive regulatory support throughout the Global Products lifecycle...
-
Regulatory Affairs Specialist
7 giorni fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoAbout UsChiesi is a global, research-driven pharmaceutical and healthcare organization with a legacy of over 85 years, operating across 31 countries and employing more than 7,000 individuals. Our mission is to enhance the quality of life for individuals while maintaining a responsible approach towards society and the environment. We focus on the research,...
-
Corporate Qa Senior Specialist
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking forMain Responsibilities- Be in charge of managing products/projects related to the respiratory area from both a qualitative and analytical point of view.- Collaborate with other functions both locally and at Corporate level (other production sites/affiliates), also interfacing with R&D, regulatory functions and external consultants.-...
-
Global Regulatory Lead
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking forPurposeThe Global Regulatory Lead contributes to the Company's success by managing the Corporate R&D Pipeline (projects in R&D Development) by providing regulatory guidance to the R&D Global Core Team as well as other non-R&D functions, as needed.Main Responsibilities1) Contributes to company success with collaboration from...
-
Specialist, Labelling
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 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,...
-
Specialist, Labelling
2 mesi fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoPress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Specialist, Labelling & Compliance Regulatory Affairs, Global Rare Diseases Date: 11 Jul 2024 Department: GRD Regulatory Affairs Team: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee ...
-
Specialist, Labelling
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoAbout us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 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...
-
Corporate QA Senior Specialist
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Main Responsibilities - Be in charge of managing products/projects related to the respiratory area from both a qualitative and analytical point of view. - Collaborate with other functions both locally and at Corporate level (other production sites/affiliates), also interfacing with R&D, regulatory functions and external...
-
Global Regulatory Lead
1 mese fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoMain Responsibilities1) Contributes to company success with collaboration from Therapeutic Area (TA) head2) Accountable for global/regional regulatory strategies for new and existing products by leading the Global Regulatory Team (GRT) for assigned projects3) Participates in OMNIS Development Core Teams 4) Leads according to established best practices5)...
-
Global Regulatory Lead
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Purpose The Global Regulatory Lead contributes to the Company’s success by managing the Corporate R&D Pipeline (projects in R&D Development) by providing regulatory guidance to the R&D Global Core Team as well as other non-R&D functions, as needed. Main Responsibilities 1) Contributes to company...
-
Global Regulatory Lead
1 mese fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoMain Responsibilities1) Contributes to company success with collaboration from Therapeutic Area (TA) head2) Accountable for global/regional regulatory strategies for new and existing products by leading the Global Regulatory Team (GRT) for assigned projects3) Participates in OMNIS Development Core Teams 4) Leads according to established best practices5)...
-
Corporate Supply Specialist
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking forPurposeThe Corporate Supply Specialist, being part of the Corporate Supply Chain department, interacts and collects inputs from functions such as Procurement, Industrialisation, Quality and Sites Planning to coordinate the S&Op processes in terms of requirements and supply granting the material availability in the short-mid term.Main...
-
Junior Regulatory Affairs
4 mesi fa
Parma, Italia Davines Italia spa A tempo pienoDavines Group is recognized for its sustainable high-end hair and skin care products commercialised under two world-renowned brands: Davines and [ comfort zone ]. We are a BCorp and our purpose is to do our best for the world, creating good life for all, through beauty, ethics and sustainability. **Junior Regulatory Affairs**: JOB MISSION The mission of...
-
Global Regulatory Lead
3 settimane fa
Parma, Italia Chiesi A tempo pienoAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 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...
-
Labelling Compliance Expert
7 giorni fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoAbout UsChiesi is a globally recognized pharmaceutical and healthcare organization headquartered in Parma, Italy, with a legacy of over 85 years. Operating across 31 countries, we are committed to enhancing the quality of life for individuals while maintaining a strong focus on social responsibility and environmental stewardship. Our innovative approach to...
