Ad Promo Manager, Americas Regulatory Affairs, Rare Diseases

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels. 
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. 

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. 
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

What we offer

Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees.   Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues.  Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."

 

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: 
  • Develop and maintain current knowledge of regulation of labeling and industry standards for labeling and communicate requirements to others as needed. 
  • Ensures appropriate implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review, approval