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

🕒 4 days ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $121k - $182k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Chiesi Group

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

Pharmaceuticals • Healthcare Insurance • Biotechnology

Chiesi Group is a global pharmaceutical company that focuses on the research, development, and commercialization of innovative medicines. Known for its commitment to improving the lives of patients, the company specializes in areas such as respiratory diseases, special care, and rare diseases. Chiesi Group emphasizes sustainability and corporate responsibility, aiming to enhance health and well-being across the globe while also being dedicated to environmental stewardship.

📋 Description

• 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. • 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 (FDA form 2253 submissions). • 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 products disease state information and external communications. • 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).

🎯 Requirements

• Bachelor’s Degree in Life Sciences or related field • 5 years of relevant 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 • 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 • Target Product Labelling experience • Experience in preparing for and participating in regulatory health authority meetings preferred

🏖️ 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