Regulatory Affairs Specialist, Labelling Compliance
6 giorni fa
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.
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