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

Chiesi Group•Cary, NC

4d•Hybrid

About The Position

This role is responsible for the maintenance of North American labeling processes, ensuring compliance with applicable Health Authorities regulations and guidelines, internal company procedures, and business objectives. The position also involves the regulatory review of advertising and promotional materials for products approved in the US and other applicable markets, and providing input to risk management activities. The role is part of Chiesi Global Rare Diseases, a business unit focused on rare and ultra-rare disorders, based in Boston, Massachusetts, with synergy with the headquarters in Parma, Italy.

Requirements

Bachelor’s Degree in Life Sciences or related field.
9 years Relevant experience in the Pharmaceutical industry, 5 years with specific experience related to regulatory labelling and promotional experience.
Experience managing complex multifunctional teams including regulatory colleagues.
Knowledge regarding global and US labelling requirements, including US Advertising and Promotional requirements
Knowledge of regulatory strategy and clinical studies.
Excellent knowledge of pharmaceutical development
Prior experience in preparation of labelling documents for new drug / biologic / device applications.
Experience with reviewing advertising materials for product launch
Project management skills with the ability to handle multiple projects and prioritize work accordingly
Experience communicating with regulatory authorities on issues related to labelling and advertising.
Human Factors labelling experience
Target Product Labelling experience

Nice To Haves

Post-graduate degree in life sciences or related field
RAC or Post-Graduate Master Certification Recommended
Experience in preparing for and participating in regulatory health authority meetings preferred.

Responsibilities

Manage activities related to the development, revision, and maintenance of product labelling including the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labelling and product artwork, Summary of Product Characteristics (SmPC), Product Monographs (PM) and related documents.
Strategically engage in product development and lifecycle management aligned to the global labelling and promotional strategy.
Support the GRDRA Therapeutic Areas cross-functional teams through labelling discussions with Health Authorities while ensuring management alignment.
Support the GRDRA Therapeutic Areas to ensure submission of labelling materials and supporting documentation to health authorities.
Support regulatory decisions related to Clinical and Global Development programs including Human Factors labelling review in accordance with health authority’s requirements.
Manage regulatory advertising and promotion efforts to ensure that activities and communications are consistent with product labelling and in compliance with relevant Health Authorities’ applicable laws, regulations and policies related to advertising & promotion of prescription products.
Lead the regulatory review of promotional materials related to marketed productsdisease state information and external communications.
Oversee the submission of advertising and promotional materials to Health Authorities in accordance with submission requirements.
Participate in risk management activities for promotional materials within Chiesi and work with other departments to ensure the regulatory perspective is appropriately communicated.
Update / review Standard Operating Procedures and internal guidance documents for related activities and provide training to Regulatory Affairs and other departments and/or affiliates as appropriate.
Interact with senior management, external departments and health authorities as needed in the activities of the Global Regulatory Affairs group.
Support audits/inspections as a global labelling lead.
Regulatory oversight of electronic systems (for example, Veeva PromoMats validation and updates).