Specialist, Labelling

4 mesi fa

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

Specialist, 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 support labelling activities and GRDRA processes.Main ResponsibilitiesOversee RIMS reporting for the GRD portfolio by:entering RIMS datacoordinating RIMS reporting by teammatessupport GRDRA in developing systems and processes for maintaining complete and accurate RIMS records that fulfill GRDRA expectationstraining GRDRA colleagues and acting as an internal resourcedesign and perform quality checks of RIMS data entered by GRDRA colleagues to assure consistency and accuracy of data being enteredcalculate and report KPIs as assigned, by extracting data from RIMSSupport 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.EducationDegree in an appropriate life science field, e.g., Pharmacology, Biological Sciences, Chemistry, Analytical Sciences, Pharmacy, or Medicine, or in an IT system field.LanguagesTechnical SkillsProficient 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, eDMSSoft SkillsPlanning and organizational skills #J-18808-Ljbffr

  • Specialist, Labelling

    4 mesi fa

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

    Specialist, 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...

  • Specialist, Labelling

    2 mesi fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

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  • Specialist, Labelling

    2 mesi fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: Sep 7, 2024 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: RD, 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 31 countries with more than...

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    Parma, Emilia-Romagna, Italia Onyx-Conseil A tempo pieno

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    Parma, Emilia-Romagna, Italia IC Resources A tempo pieno

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    Parma, Emilia-Romagna, Italia IC Resources A tempo pieno

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