Director, Regulatory Affairs Labeling

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities

• Lead cross-functional teams in the development and maintenance of labeling content, including USPI, SmPC, IFU, PPI, and CDS.
• Manage labeling development, review, and approval workflows, including related meetings, documents, and labeling change controls.
• Maintain labeling expertise regarding U.S. requirements and stay current with labeling guidelines and regulations from the FDA, EMA, and other applicable authorities, as needed.
• Serve as the regulatory representative on the Promotional Review Committee (PRC) and the Medical Review Committee (MRC) for assigned activities.
• Be responsible for regulatory submissions of labeling and promotional materials to the FDA.
• Provide insight, sound judgment, and clear direction to Commercial and Medical teams during the development, review, and approval of product labeling, advertising and promotion materials, and disease awareness campaigns.
• Identify and provide guidance on the development and improvement of policies, processes, and standards for promotional materials and related activities.
• Maintain regulatory expertise in product promotion compliance by staying current with FDA enforcement actions and monitoring trends.
• Take a hands-on approach while also setting strategy.
• Provide risk assessments of promotional campaigns in a fast-paced environment.
• Interpret and communicate regulatory expectations to internal and external stakeholders to execute program objectives in compliance with applicable regulations.
• Contribute to the strategic leadership and development of policies, procedures, and best practices commensurate with the requirements of a rapidly growing company.

Standout Skills for Impact

• Experienced regulatory professional who can provide guidance and influence negotiations and outcomes within the Labeling Working Group and Promotional Review Committee. Expert knowledge of FDA labeling, advertising, and promotion regulations and guidelines.
• Expert understanding of FDA labeling regulations and guidelines, with responsibility for establishing and overseeing the labeling function at Kiniksa.
• Demonstrated ability to influence others and foster team collaboration

Qualifications and Experience

• BA/BS degree and a minimum of 8-10 years of pharmaceutical or biopharmaceutical industry experience, including at least 5 years of regulatory affairs experience focused on reviewing advertising and promotion materials for prescription drug and/or biologic products.
• Prior experience and success in launching new products or additional indications.
• Strong leadership and communication skills, with experience working across multiple functional areas in a matrixed team environment.
• Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience
• Ability to thrive in a collaborative and fast-paced team environment
• Experience communicating and negotiating directly with FDA.
• Expert understanding of FDA advertising and promotion regulations and guidelines specific to pharmaceutical and biopharmaceutical products.
• Expert understanding of FDA labeling regulations and guidelines
• Experience writing labeling documents (USPI, Instructions for Use, SmPC, etc.).
• Strong interpersonal, oral, and written communication skills.
• Demonstrated ability to influence others and foster team collaboration
• High level of initiative and commitment