Overview AD / Lead, Advertising and Promotion / Commercial Labeling, Americas Regulatory Affairs, GRD – Based in Parma, Italy. Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years of experience, operating in 30 countries with more than 6,000 employees. The group develops and markets innovative drugs in AIR, RARE, and CAR E therapeutic areas. Chiesi USA is a specialty pharmaceutical company focused on hospital, adjacent specialty and rare disease markets. Chiesi USA is a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. We value diversity, inclusion and equal opportunities across cultures, genders, generations, ethnicities, abilities, and identities. 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 role provides input to risk management activities, manages the labeling control process (including new labeling and changes to existing labeling), and submits labeling information to regulatory authorities in the United States and Canada. Main Responsibilities

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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 and coordinate with authors, reviewers, and approvers to obtain content approval to support business needs.

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.

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 areas, modalities, competitor promotions, and prepare complaint letters to OPDP as needed.

Monitor US regulatory promotional environment by reviewing guidelines, untitled letters, and warning letters; participate in major industry/FDA meetings (e.g., FDLI, DIA).

Ensure changes in US Prescribing Information are reflected in current promotions and advertising.

Contribute to the development and implementation of regulatory training programs for cross-functional partners.

Process improvement: map processes, identify bottlenecks, provide solutions, and author new process documents with cross-functional teams.

Direct and oversee promotional labeling during launch preparation.

Labeling Responsibilities: Develop and maintain current knowledge of labeling regulation and industry standards; communicate requirements to others as needed.

Lead the development and implementation of Chiesi Global Rare Disease procedures for 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.

Provide input to risk management activities and collaborate with other departments to communicate product risks.

Prepare Standard Operating Procedures and provide training related to Regulatory Affairs and other departments as appropriate.

Review and provide input on regulatory guidance documents impacting domestic and international activities related to Regulatory.

Interact with senior management, external departments, and regulatory authorities as needed in GRDRA activities.

Experience Required

Minimum 12 years in Pharmaceutical/Biotechnology industry, with at least 8 years in Regulatory Affairs and advertising and promotion review/approval of marketed prescription drugs. Direct Rare Disease drug development experience is a plus.

Excellent understanding of US regulations for drug promotion/advertising and US labeling; experience with FDA OPDP interactions.

Experience with Veeva Vault PromoMats and MedComms, Trackwise, or similar document management systems is a plus.

Demonstrated expertise in regulatory requirements for labeling and advertising materials; ability to read and interpret regulatory guidance and implement changes to ensure compliance. Knowledge of Common Technical Document and global labeling guidelines preferred.

Familiarity with the drug development process and experience in preparing original submissions for new drugs; experience creating and reviewing labeling and advertising materials.

Experience working on collaborative multifunctional teams at local or global levels.

Ability to manage multiple tasks and resources concurrently, adapt to changing priorities and deadlines.

Strong communication skills with all levels in local and global environments.

Shared philosophy with Global Rare Diseases, acknowledging that patients and caregivers are central to initiatives.

Education

Bachelor's degree in life sciences or related field required. Advanced degree and/or Regulatory Affairs Certification (RAC) required.

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 with resources and training. We offer top-class benefits, including comprehensive healthcare, work-life balance initiatives, relocation support, competitive salary with bonuses, flexible working arrangements, remote options, and tax assistance for foreign colleagues. Equal Opportunity Employer Chiesi USA is an equal opportunity employer committed to hiring a diverse workforce. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other protected basis. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination. Helping all candidates find great careers is our goal. The information you provide is secure and confidential. We are directing you to the original job posting. Please apply directly for this job at the employer site.

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