Job Description

Associate Director, Regulatory Affairs Advertising and Promotion Americas, GRD

Date: Sep 14, 2025

Department: GRD Regulatory Affairs

Job Type: Direct Employee

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Contract Type: Permanent

Location: Boston, MA, US

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). We develop and market innovative drugs in three therapeutic areas: AIR, RARE and CARE. We are a B Corp certified company with high social and environmental standards and a commitment to diversity, inclusion and equal opportunities.

Who we are looking for

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 also provides input to risk management activities, manages the labeling control process (including generation of new labeling and changes to existing labeling), and submits labeling information to regulatory authorities in the United States and Canada.

Main Responsibilities

• Promotional Material/External Communications Responsibilities
  • Lead Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, with additional duties in Canada.
  • Manage and oversee submission of promotional labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.
  • Facilitate review meetings and coordinate with authors, reviewers/approvers to obtain content approval.
  • Contribute to regulatory strategy for promotional labeling, core sales training materials, and other communications (social media, press releases, talking points).
  • Ensure regulatory compliance while effectively managing business risks.
  • Understand global promotional strategies and provide solutions to local US regulatory promotional issues.
  • Monitor competitive activities and prepare complaint letters to OPDP as needed.
  • Review regulatory promotional guidelines and attend industry/FDA meetings as appropriate.
  • Ensure changes in US Prescribing Information are reflected in current promotions and advertising.
  • Contribute to regulatory training programs for cross-functional partners.
  • Process improvement: map processes, identify bottlenecks, and author new process documents.
  • Direct and oversee promotional labeling during launch preparation.
• Labeling Responsibilities
  • Develop knowledge of labeling regulations and communicate requirements as needed.
  • Lead development and implementation of procedures for labeling preparation, launch prep, review, approval, and submission.
  • Manage and oversee the labeling control process for tracking, implementation and regulatory submission of labeling changes.
• Provide input to risk management activities and coordinate with other departments to ensure product risks are communicated.
• Prepare Standard Operating Procedures and provide training to Regulatory Affairs and other departments as appropriate.
• Review and provide input on regulatory guidance documents impacting domestic and international activities.
• Interact with senior management, external departments and regulatory authorities as needed in GRDRA activities.

Experience Required

• Minimum 12 years of Pharmaceutical/Biotechnology experience, with at least 8 years in Regulatory Affairs and advertising and promotion review/approval of marketed prescription drugs. Direct experience with rare disease drug development is a plus.
• Excellent understanding of US regulations for drug promotion/advertising and US labeling, with experience interacting with FDA OPDP.
• Experience with Veeva Vault PromoMats and MedComms, Trackwise or similar systems is a plus.
• Demonstrated expertise in regulatory requirements for labeling and advertising materials; familiarity with Common Technical Document and global labeling guidelines preferred.
• Experience with original submissions for new drugs and in creating/reviewing labeling and advertising materials.
• Experience working on collaborative multifunctional teams at local or global levels.
• Ability to manage multiple tasks and adapt to rapidly changing priorities and deadlines.
• Experience communicating with all levels of personnel in local and global environments.
• Shared philosophy with Global Rare Diseases, prioritizing patients and caregivers as central to initiatives.

Education

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

What we offer

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and relocation support. Salary includes base pay, performance bonuses, and market-competitive benefits. Flexible working arrangements, remote options, and tax assistance for foreign colleagues are available to help you thrive.

Chiesi USA is an equal opportunity employer committed to hiring a diverse workforce. All qualified applicants receive consideration without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by law.

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