Regulatory Affairs Manager
Toronto, CA
Chiesi USA
Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. 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, inclusion, and equal opportunity 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.
Who we are looking for
This is what you will do
We are seeking a motivated and detail-oriented Intern to join our team to gain hands-on experience in Regulatory Affairs. This internship offers exposure to a wide range of international regulatory environments, and cooperation between various groups within Chiesi Global Rare Diseases. You will collaborate with the Labelling & Compliance team within Regulatory Affairs, to analyse and document product labels and core data sheets.
You’ll be responsible for:
- Analyse labels from across international markets and compare and contrast label content
- Document differences in regulatory requirements between major regulatory markets
- Compare patient friendly language used in package leaflets to physician directed language
- Support cross-functional teams for the development and internal review of company core data sheets
You will need to have
- Currently pursuing experience in Regulatory Affairs, a background in pharmaceutical related science is an asset.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office Suite.
- Detail-oriented, organized, and able to work collaboratively.
- Enthusiastic about learning and contributing to a fast-paced environment.
Location
Hybrid - One day per week onsite
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
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