Manager, Americas Regulatory Affairs Labeling & Promotion, Global Rare Diseases (Boston, MA, US)

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:

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:

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:

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 and internal guidance documents for related activities and provide training to Regulatory Affairs and other departments and/or affiliates as appropriate.

Interact with senior management, external departments and health authorities as needed in the activities of the Global Regulatory Affairs group.

Support audits/inspections as a global labelling lead.

Regulatory oversight of electronic systems (for example, Veeva PromoMats validation and updates).

You will need to have

Bachelor’s Degree in Life Sciences or related field.

5 years of relevant experience related to regulatory labelling and promotional experience.

Experience managing complex multifunctional teams including regulatory colleagues.

Knowledge regarding global and US labelling requirements, including US Advertising and Promotional requirements

Knowledge of regulatory strategy and clinical studies.

Excellent knowledge of pharmaceutical development

Prior experience in preparation of labelling documents for new drug / biologic / device applications.

Experience with reviewing advertising materials for product launch

Project management skills with the ability to handle multiple projects and prioritize work accordingly

Experience communicating with regulatory authorities on issues related to labelling and advertising. Experience in preparing for and participating in regulatory health authority meetings preferred.

Target Product Labelling experience

We would prefer for you to have

Post-graduate degree in life sciences or related field

RAC or Post-Graduate Master Certification Recommended

Location

Remote position, candidates based in Eastern or Central US time zones will be considered. #LI-Remote

Compensation

The annual base pay for this position ranges from $121,000 to $150,000. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

What we offer

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.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business.  All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.

]]>