Specialist, Labelling

Specialist, Labelling & Compliance Regulatory Affairs, Global Rare DiseasesDate: Jul 11, 2024
Department: GRD Regulatory Affairs
Job Type: Direct Employee
Team: R&D, Pharmacovigilance & Regulatory Affairs
Contract Type: Permanent
Location: Parma, IT
PurposeTo 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

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