Manager, Regulatory Affairs – Labeling & Promotion, Global Rare Diseases

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Accountable for the upkeep of North American labelling processes, ensuring adherence to relevant Health Authorities regulations and guidelines, internal company protocols, and business goals.

• Responsible for the regulatory evaluation of advertising and promotional materials for products sanctioned in the US market and other applicable regions.

• Oversee activities associated with the creation, modification, and maintenance of product labelling, including the Company Core Data Sheet (CCDS), United States Package Insert (USPI), and related patient labelling and product artwork, Summary of Product Characteristics (SmPC), Product Monographs (PM), and associated documents.

• Actively engage in product development and lifecycle management in alignment with the global labelling and promotional strategy.

• Assist the GRDRA Therapeutic Areas cross-functional teams in labelling discussions with Health Authorities while ensuring alignment with management.

• Aid the GRDRA Therapeutic Areas in the submission of labelling materials and supporting documentation to health authorities (including FDA form 2253 submissions).

• Oversee regulatory advertising and promotional initiatives to ensure that activities and communications are in line with product labelling and comply with applicable laws, regulations, and policies set forth by Health Authorities regarding the advertising and promotion of prescription products.

• Lead the regulatory assessment of promotional materials pertinent to marketed products, including disease state information and external communications.

• Engage in risk management activities for promotional materials within Chiesi and collaborate with other departments to ensure the regulatory viewpoint is effectively communicated.

• Update and review Standard Operating Procedures and internal guidance documents for related tasks and provide training to Regulatory Affairs and other departments and/or affiliates as necessary.

• Liaise with senior management, external departments, and health authorities as needed within the Global Regulatory Affairs group.

• Provide support during audits and inspections as a global labelling lead.

• Exercise regulatory oversight of electronic systems, such as Veeva PromoMats validation and updates.

⛳️ Requirements

• Bachelor’s Degree in Life Sciences or a related field.

• 5 years of pertinent experience in regulatory labelling and promotional activities.

• Experience managing complex multifunctional teams that include regulatory colleagues.

• Knowledge of global and US labelling standards, including US Advertising and Promotional guidelines.

• Strong understanding of pharmaceutical development processes.

• Previous experience in creating labelling documents for new drug, biologic, or device applications.

• Familiarity with reviewing advertising materials for product launches.

• Project management capabilities with the skill to manage multiple projects and prioritize tasks effectively.

• Experience in communication with regulatory authorities regarding labelling and advertising issues.

• Experience in Target Product Labelling.

• Preferred experience in preparing for and participating in regulatory health authority meetings.

🏝️ Benefits

• Comprehensive healthcare programs.

• Work-life balance initiatives.

• Robust relocation support.

• Performance bonuses.

• Flexible working arrangements.

• Remote work options.

• Tax assistance services for foreign colleagues.