Manager, Americas Regulatory Affairs Labeling & Promotion, Global Rare Diseases
Chiesi GroupAbout the role
About Us
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
- Responsible for maintenance of North American labelling processes ensuring compliance with applicable Health Authorities regulations and guidelines, internal company procedures and business objectives.
- Responsible for the regulatory review of advertising and promotional materials for products approved in the US market and other markets as applicable.
- This position is also responsible for providing input to risk management activities.
You’ll be responsible for:
Labelling Responsibilities:
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- Manage activities related to the development, revision, and maintenance of product labelling including the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labelling and product artwork, Summary of Product Characteristics (SmPC), Product Monographs (PM) and related documents.
- Strategically engage in product development and lifecycle management aligned to the global labelling and promotional strategy.
- Support the GRDRA Therapeutic Areas cross-functional teams through labelling discussions with Health Authorities while ensuring management alignment.
- Support the GRDRA Therapeutic Areas to ensure submission of labelling materials and supporting documentation to health authorities (FDA form 2253 submissions).
- Support regulatory decisions related to Clinical and Global Development programs in accordance with health authority’s requirements.
Promotional Labelling/External Communications Responsibilities:
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- Manage regulatory advertising and promotion efforts to ensure that activities and communications are consistent with product labelling and in compliance with relevant Health Authorities’ applicable laws, regulations and policies related to advertising & promotion of prescription products.
- Lead the regulatory review of promotional materials related to marketed products disease state information and external communications.
- Oversee the submission of advertising and promotional materials to Health Authorities in accordance with submission requirements.
Additional Responsibilities:
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- Participate in risk management activities for promotional materials within Chiesi and work with other departments to ensure the regulatory perspective is appropriately communicated.
- Update / review Standard Operating Procedures
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