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."
Who we are looking for
Purpose
Responsible for maintenance of global 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. Preferred candidates will be able to work hybrid model out of Cary, NC office.
Main Responsibilities
Labelling Responsibilities:
- Manage activities related to the development, revision, and maintenance of product labelling including the Company Core Data Sheet (CCDS), Target Product Labelling (TPL), United States Package Insert (USPI) and associated patient labelling and product artwork, Summary of Product Characteristics (SmPC), and related documents.
- Strategically engage in product development and lifecycle management aligned to the global labelling and promotional strategy.
- Support the GRA Therapeutic Areas cross-functional teams through labelling discussions with Health Authorities while ensuring management alignment.
- Support the GRA Therapeutic Areas to ensure submission of labelling materials and supporting documentation to health authorities.
- Support regulatory decisions related to Clinical and Global Development programs including Human Factors labelling review 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.
- Provide input to support trial designs within Chiesi to ensure alignment to Target Product Profile and Target Product Labelling.
- Support audits/inspections as a global labelling lead.
- Regulatory oversight of electronic systems (for example, Veeva PromoMats validation and updates).
Experience Required
- 9 years relevant experience in the Pharmaceutical industry
- 5 years with specific 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.
- Human Factors labelling experience
- Target Product Labelling experience
Education
Bachelor's Degree in Life Sciences or related field
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, sexual orientation, marital status, veteran status, gender identity or expression 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.
Chiesi
Jan 24, 2025