Specialist, Labelling & Compliance Regulatory Affairs, Global Rare Diseases

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 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.

Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

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.

This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.

Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.

What we are looking for
This is what you will do
Reporting to the Head, Labelling & Compliance Regulatory Affairs, Global Rare Diseases, the Specialist, Labelling & Compliance Regulatory Affairs will contribute to the 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.

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.

You will need to have

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 organize and chair…