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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...
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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...
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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,...
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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 ...
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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...
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Specialist, Labelling
2 mesi 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...
Specialist, Labelling
2 mesi fa
Specialist, Labelling & Compliance Regulatory Affairs, Global Rare Diseases Date: Jul 11, 2024
Department: GRD Regulatory Affairs
Job Type: Direct Employee
Team: R&D, Pharmacovigilance & Regulatory Affairs
Contract Type: Permanent
Location: Parma, IT
Purpose To contribute to and oversee GRDRA regulatory information and documentation managed in RIMS and eDMS, and to support labelling activities and GRDRA processes.
Main Responsibilities Oversee RIMS reporting for the GRD portfolio by: entering RIMS data
coordinating RIMS reporting by teammates
support GRDRA in developing systems and processes for maintaining complete and accurate RIMS records that fulfill GRDRA expectations
training GRDRA colleagues and acting as an internal resource
design and perform 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.
Experience Required +2 years' experience in Regulatory Affairs preferably with exposure to international regulatory jurisdictions.
Education Degree in an appropriate life science field, e.g., Pharmacology, Biological Sciences, Chemistry, Analytical Sciences, Pharmacy, or Medicine, or in an IT system field.
Languages Technical Skills 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
Soft Skills Planning and organizational skills
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