Specialist, Labelling & Compliance Regulatory Affairs, Global Rare Diseases
Department: GRD Regulatory Affairs
Business Area: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Parma, IT
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. Over 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.
Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a 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. This unit is based in Boston, Massachusetts, with strong synergy with the headquarters in Parma. The unit focuses on lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies, and partners with global leaders in scientific research, patient advocacy and care.
Responsibilities
Reporting to the Head, Labelling & Compliance Regulatory Affairs, Global Rare Diseases, the Specialist, Labelling & Compliance Regulatory Affairs will contribute to labelling and compliance activities managed by GRDRA, with guidance of the Line Manager. They will contribute to and oversee GRDRA regulatory information and documentation managed in RIMS and eDMS.
You will be responsible for
* Contribute to accurate RIMS reporting for the GRD portfolio by assisting GRDRA in entering RIMS data, coordinating RIMS reporting by teammates, and training GRDRA colleagues on consistent use.
* Track and monitor fulfilment of regulatory obligations, with guidance of the Line Manager.
* Support GRDRA in developing systems and processes for maintaining complete and accurate RIMS records that fulfil GRDRA expectations.
* 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 Senior Manager, Compliance, RA by contributing to inspection preparation and readiness, calculating and reporting KPIs using RIMS data, and coordinating SOP training to ensure group members' training remains current.
* Support GRDRA 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.
* Legalise 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.
Qualifications
* Degree in an appropriate life science field, e.g., Pharmacology, Biological Sciences, Chemistry, Analytical Sciences, Pharmacy, or Medicine, or in an IT system field. College diploma in Regulatory Affairs an asset.
* Some experience in Regulatory Affairs preferably with exposure to international regulatory jurisdictions.
* 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.
* Ability to organise and chair meetings, facilitate discussions and prepare and distribute minutes.
* Highly organised; able to coordinate personal deliverables and negotiate the deliverables from teammates to deliver on time.
* Ability to interact effectively with staff at all levels.
* Excellent English written and oral communication skills.
* Proficient in MS Office, Adobe Acrobat, RIMS, eDMS.
Location
The role is based in the HQ in Parma, Italy, with a hybrid working arrangement combining remote work and presence in the office.
Compensation Range
The minimum salary for this role is €39.760, aligned to our established salary framework. The final offer will reflect the candidate's skills, experience, qualifications and internal equity considerations.
In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme and flexible benefits programme.
Benefits
We provide a range of benefits, including comprehensive healthcare programmes, work‐life balance initiatives, and robust relocation support. The salary package is competitive and includes a basic salary, performance bonuses, and benefits benchmarked against the external market. Flexible working arrangements, remote work options, and tax assistance services for foreign colleagues are also available.
Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws.
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