Ad Promo Manager, Americas Regulatory Affairs, Global Rare Diseases

Chiesi USA

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in 31 countries. More than 7,000 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.

Who we are looking for

Purpose

Responsible for the regulatory review and submission of advertising and promotional materials for multiple Chiesi Global Rare Disease products in the United States. This position is also responsible for providing input to risk management activities, working in the labeling control process, including generation of new labeling and changes to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada.

Main Responsibilities

Promotional Material / External Communications Responsibilities :

• Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, with additional duties in Canada.
• Manage and oversee the submission of promotional labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.
• Facilitate review meetings online and offline coordination with authors, reviewers / approvers to get content approved to support business needs
• Ensures regulatory compliance while effectively managing business risks
• Understands global promotional strategies and provides solutions to local US regulatory promotional issues
• Maintains awareness of competitive activities by monitoring assigned rare disease therapeutic areas, modalities, competitor products promotional activities, and prepares complaint letters to OPDP as needed.
• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled, and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry / FDA meetings.
• Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
• Actively contributes to the development and implementation of regulatory training programs for cross-functional partners.

Labeling Responsibilities :

Risk Management Responsibilities :

Experience Required

Education

Compensation Data

The annual base pay for this position ranges from $120,420 to $147,180. 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.