Specialist, Labelling

Date: Sep 7, 2024

Department: GRD Regulatory Affairs

Job Type: Direct Employee

Team: R&D, 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 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, develops and markets innovative drugs in its main therapeutic areas.

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a Chiesi Group's business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.

The unit is headquartered in Boston, Massachusetts, and has an initial focus on research and product development for lysosomal storage diseases, rare hematology and ophthalmology disorders. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care.

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 fulfil 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 Fluent in English

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 Team working Communication skills What we offer You would join a dynamic, fast-growing, challenging and friendly environment. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well-being. We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

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