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

This is what you will do

• Responsible for maintenance of North American labelling processes ensuring compliance with applicable Health Authorities regulations and guidelines, internal company procedures and business objectives.
• Responsible for the regulatory review of advertising and promotional materials for products approved in the US market and other markets as applicable. 
• This position is also responsible for providing input to risk management activities.

You’ll be responsible for:

Labelling 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.

Promotional Labelling/External Communications Responsibilities:

• • 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.

Additional Responsibilities:

• • 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).

You will need to have

• 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. Experience in preparing for and participating in regulatory health authority meetings preferred. 
• Human Factors labelling experience 
• Target Product Labelling experience

We would prefer for you to have

• Post-graduate degree in life sciences or related field
• RAC or Post-Graduate Master Certification Recommended

Location

Hybrid position based in Cary, NC. #LI-Hybrid