Regulatory Affairs Specialist, Labelling Compliance

5 giorni fa

Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

Job Summary

Chiesi Farmaceutici S.P.A. is seeking a highly skilled Regulatory Affairs Specialist, Labelling Compliance to contribute to and oversee regulatory information and documentation managed in RIMS and eDMS, and to support labelling activities and processes.

Main Responsibilities

  • Oversee RIMS reporting for the GRD portfolio by entering RIMS data, coordinating RIMS reporting by team members, and supporting GRDRA in developing systems and processes for maintaining complete and accurate RIMS records.
  • Train GRDRA colleagues and act as an internal resource, designing and performing quality checks of RIMS data entered by GRDRA colleagues to assure consistency and accuracy of data being entered.
  • Calculate and report KPIs as assigned, by extracting data from RIMS.
  • Support the Manager, Compliance, RA in the preparation for inspections and inspection readiness.
  • Support RA in the preparation, update, and maintenance of company core data sheets, and of local labelling, as assigned.
  • Evaluate local labels and conduct gap analyses between local labels and the CCDS.
  • Legalize documents in support of various international submissions on behalf of GRDRA as assigned.
  • Perform all work in accordance with established regulatory, compliance, and safety requirements.

Requirements

  • +2 years' experience in Regulatory Affairs preferably with exposure to international regulatory jurisdictions.
  • Degree in an appropriate life science field, e.g., Pharmacology, Biological Sciences, Chemistry, Analytical Sciences, Pharmacy, or Medicine, or in an IT system field.
  • Proficient in the use of a RIMS and a document management system.
  • Familiarity with the eCTD structure, and ability to identify, evaluate, and characterize gaps in regulatory information.
  • Familiarity with the stages of drug development and regulatory life cycle management.
  • Committed to working in a team environment with teammates who are widely geographically distributed.
  • Able to organize and chair meetings, facilitate discussions, and prepare and distribute minutes.
  • Highly organized; able to coordinate personal deliverables and negotiate the deliverables from teammates to deliver on time.
  • Ability to interact effectively with staff at all levels.
  • Proficient in MS Office, Adobe Acrobat, RIMS, eDMS.

  • Labelling Compliance Expert

    5 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About 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...

  • Labelling Compliance Expert

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About 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...

  • Regulatory Affairs Specialist, Labeling

    5 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About UsChiesi Group is a leading international pharmaceutical and healthcare company with a rich history of innovation and commitment to improving people's quality of life. With over 85 years of experience, we operate in 31 countries and employ over 7,000 dedicated professionals.Our MissionWe strive to achieve our mission by researching, developing, and...

  • Regulatory Affairs Specialist, Labeling

    6 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About UsChiesi Group is a leading international pharmaceutical and healthcare company with a rich history of innovation and commitment to improving people's quality of life. With over 85 years of experience, we operate in 31 countries and employ over 7,000 dedicated professionals.Our MissionWe strive to achieve our mission by researching, developing, and...

  • Regulatory Affairs Specialist

    5 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About 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,...

  • Regulatory Affairs Specialist

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About 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,...

  • Regulatory Compliance Specialist

    5 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Main ResponsibilitiesAs a key member of the Chiesi Group, you will be responsible for ensuring the quality compliance to pharmaceutical standards and internal procedures. This includes guaranteeing the regulatory compliance of production and analytical documents and processes to Global registration dossier.Key Activities• Provide Global Products life-cycle...

  • Regulatory Compliance Specialist

    6 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Main ResponsibilitiesAs a key member of the Chiesi Group, you will be responsible for ensuring the quality compliance to pharmaceutical standards and internal procedures. This includes guaranteeing the regulatory compliance of production and analytical documents and processes to Global registration dossier.Key Activities• Provide Global Products life-cycle...

  • Corporate Compliance Officer for Regulatory Affairs

    5 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Who 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...

  • Corporate Compliance Officer for Regulatory Affairs

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Who 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...

  • Global CMC Regulatory Affairs Senior Specialist

    2 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Who We Are Looking For Purpose Responsible for: • Developing and implementing comprehensive and innovative Regulatory-CMC strategies globally, covering the entire product life-cycle (pre-clinical, clinical, post-market and change management) for Chiesi's global offerings, including chemically synthesized products, biologics, and medical devices...

  • Regulatory Compliance Specialist in Pharmaceuticals

    5 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Who 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...

  • Regulatory Compliance Specialist in Pharmaceuticals

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Who 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...

  • Global CMC Regulatory Affairs Senior Expert

    4 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Who We Are Looking For Purpose Responsible for: • Developing and implementing comprehensive and innovative Regulatory-CMC strategies on a global scale, covering the entire product life-cycle (from pre-clinical to clinical phases, as well as life-cycle and change management) for Chiesi's global offerings, including chemically synthesized products,...

  • Trainee in Global Compliance

    5 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Who we are looking for Purpose The Global Compliance Function at Chiesi Group, established to uphold international standards in ethics, anti-bribery, and antitrust, plays a crucial role in the Group Legal & Corporate Affairs Department. This function aims to enhance adherence to these standards and improve coordination across the Group. In 2023, the...

  • Trainee in Global Compliance

    2 settimane fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Who we are looking for Purpose The Global Compliance Function at Chiesi Group, established to uphold international standards in ethics, anti-bribery, and antitrust, plays a crucial role in the Group Legal & Corporate Affairs Department. This function aims to enhance adherence to these standards and improve coordination across the Group. In 2023, the...

  • Specialista di Compliance e Qualità per la Ricerca e Sviluppo Globale

    5 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Descrizione del LavoroLa Chiesi Group è un'azienda farmaceutica leader nel settore della ricerca e sviluppo di nuove terapie. Come Specialista di Compliance e Qualità per la Ricerca e Sviluppo Globale, sei responsabile di assicurare che il sistema di qualità di farmacovigilanza sia conforme ai requisiti regolatori applicabili e agli standard di qualità...

  • Specialista di Compliance e Qualità per la Ricerca e Sviluppo Globale

    6 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    Descrizione del LavoroLa Chiesi Group è un'azienda farmaceutica leader nel settore della ricerca e sviluppo di nuove terapie. Come Specialista di Compliance e Qualità per la Ricerca e Sviluppo Globale, sei responsabile di assicurare che il sistema di qualità di farmacovigilanza sia conforme ai requisiti regolatori applicabili e agli standard di qualità...

  • Senior Quality Assurance Specialist

    10 ore fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About the RoleChiesi Group is seeking a highly experienced Senior Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for managing products/projects related to the respiratory area from a qualitative and analytical perspective.Main ResponsibilitiesCollaborate with cross-functional teams...

  • Medical Device Specialist

    6 giorni fa

    Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About the RoleWe are seeking a highly skilled Medical Device Specialist to join our team at Chiesi Group. As a key member of our Pharmacovigilance team, you will play a critical role in ensuring the safe use of medical devices and food supplements across our organization.Key ResponsibilitiesDesign, plan, maintain, and update medical device, food supplement,...