Chiesi Farmaceutici S.p.A.
Ad Promo Manager, Americas Regulatory Affairs, Global Rare Diseases
Chiesi Farmaceutici S.p.A., Boston, Massachusetts, us, 02298
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Ad Promo Manager, Americas Regulatory Affairs, Global Rare Diseases
Date: Aug 29, 2025 Department: GRD Regulatory Affairs Job Type: Direct Employee Location: Boston, MA, US About us Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years’ experience, operating in 30 countries with more than 6,000 employees. The Group develops and markets innovative drugs in AIR, RARE and CARE therapeutic areas. We are a B Corp and promote diverse, inclusive and ethical practices. We are committed to equal opportunities for all. 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. Ensure regulatory compliance while effectively managing business risks. Understand global promotional strategies and provide solutions to local US regulatory promotional issues. Maintain awareness of competitive activities by monitoring assigned rare disease therapeutic areas, modalities, competitor products promotional activities, and prepare complaint letters to OPDP as needed. Monitor US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attending major FDLI, DIA and other industry/FDA meetings. Ensure that changes in US Prescribing Information are reflected in current promotions and advertising. Actively contribute 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. Ensure appropriate implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review, approval, and submission. Manage the labeling control process for tracking, implementation and regulatory submission of changes to new or existing labeling. Provide input to risk management activities within Chiesi and work with other departments to ensure product risks are appropriately communicated. Provide training to Regulatory Affairs and other departments as appropriate. Review and provide input and communicate externally on regulatory guidance documents that impact US activities related to Regulatory activities. Interact with senior management, external departments and regulatory authorities as needed in the activities of GRDRA. Experience Required
Minimum 5 years Pharmaceutical/Biotechnology industry experience, at least 3 years Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs. Excellent understanding of US regulations for drug promotion/advertising and US labeling, and experience interacting with FDA OPDP. Experience with Veeva Vault PromoMats and MedComms, Trackwise, or similar document management systems a plus. Demonstrated expertise in regulatory requirements for labeling and advertising materials. Experience in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance. Knowledge of Common Technical Document and global guidelines on content and format of labeling preferred. Experience with creating and reviewing labeling and advertising materials required. Experience on collaborative multifunctional work teams at the local or global level. Ability to manage multiple tasks and multifunctional resources concurrently, and to respond to rapidly changing priorities and aggressive deadlines. Experience in communicating with all levels of personnel, in local and global environments. Shared philosophy with Global Rare Diseases, acknowledging that patients and their caregivers are the central driving force behind all initiatives. Education
Bachelor’s degree in life sciences or related field required. Advanced degree and/or Regulatory Affairs Certification (RAC) credential a plus. What we offer 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 workforce 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. Discover all our opportunities Screen readers cannot read the following searchable map.
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Date: Aug 29, 2025 Department: GRD Regulatory Affairs Job Type: Direct Employee Location: Boston, MA, US About us Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years’ experience, operating in 30 countries with more than 6,000 employees. The Group develops and markets innovative drugs in AIR, RARE and CARE therapeutic areas. We are a B Corp and promote diverse, inclusive and ethical practices. We are committed to equal opportunities for all. 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. Ensure regulatory compliance while effectively managing business risks. Understand global promotional strategies and provide solutions to local US regulatory promotional issues. Maintain awareness of competitive activities by monitoring assigned rare disease therapeutic areas, modalities, competitor products promotional activities, and prepare complaint letters to OPDP as needed. Monitor US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attending major FDLI, DIA and other industry/FDA meetings. Ensure that changes in US Prescribing Information are reflected in current promotions and advertising. Actively contribute 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. Ensure appropriate implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review, approval, and submission. Manage the labeling control process for tracking, implementation and regulatory submission of changes to new or existing labeling. Provide input to risk management activities within Chiesi and work with other departments to ensure product risks are appropriately communicated. Provide training to Regulatory Affairs and other departments as appropriate. Review and provide input and communicate externally on regulatory guidance documents that impact US activities related to Regulatory activities. Interact with senior management, external departments and regulatory authorities as needed in the activities of GRDRA. Experience Required
Minimum 5 years Pharmaceutical/Biotechnology industry experience, at least 3 years Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs. Excellent understanding of US regulations for drug promotion/advertising and US labeling, and experience interacting with FDA OPDP. Experience with Veeva Vault PromoMats and MedComms, Trackwise, or similar document management systems a plus. Demonstrated expertise in regulatory requirements for labeling and advertising materials. Experience in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance. Knowledge of Common Technical Document and global guidelines on content and format of labeling preferred. Experience with creating and reviewing labeling and advertising materials required. Experience on collaborative multifunctional work teams at the local or global level. Ability to manage multiple tasks and multifunctional resources concurrently, and to respond to rapidly changing priorities and aggressive deadlines. Experience in communicating with all levels of personnel, in local and global environments. Shared philosophy with Global Rare Diseases, acknowledging that patients and their caregivers are the central driving force behind all initiatives. Education
Bachelor’s degree in life sciences or related field required. Advanced degree and/or Regulatory Affairs Certification (RAC) credential a plus. What we offer 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 workforce 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. Discover all our opportunities Screen readers cannot read the following searchable map.
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