Assoc Director, Advertising and Promotion, Commercial Labeling Lead, Americas Reg Affairs, GRD

Purpose

Responsible for the regulatory review and submission of advertising and promotional materials for all Chiesi Global Rare Disease products in the United States.  This position is also responsible for providing input to risk management activities, managing 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:

• Heads 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 
• Actively contribute to the development and implementation of regulatory strategy for promotional labeling, core sales training materials, and other communications including social media, press releases, and talking points
• 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.
• Process improvement: work with Company cross-functional team to map the process, identify bottlenecks, provide solutions, and author new process documents.
• Direct and oversee promotional labeling during launch preparation.

Labeling Responsibilities: 

• Develop and maintain current knowledge of regulation of labeling and industry standards for labeling and communicate requirements to others as needed. 
• Lead the development and implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review, approval, and submission.
• Manage and oversee the labeling control process for tracking, implementation and regulatory submission of changes to new or existing labeling.

Risk Management Responsibilities: 

• Provide input to risk management activities within Chiesi and work with other departments to ensure product risks are appropriately communicated. 
• Prepare Standard Operating Procedures for related activities and provide training to Regulatory Affairs and other departments as appropriate. 
• Review and provide input and communicate externally on regulatory guidance documents that impact domestic and international activities related to Regulatory activities. 
• Interact with senior management, external departments and regulatory authorities as needed in the activities of GRDRA.

Experience Required

•    Advanced degree and/or Regulatory Affairs Certification (RAC) credential required. 
•    Minimum 8 years Pharmaceutical/Biotechnology industry experience, at least 5 years Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs.   Direct experience with rare disease drug development a plus.
•    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.
•    Familiarity in the drug development process and prior experience in preparation of original submissions for new drugs 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.