The posting
Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.
Reporting to the Executive Director, Regulatory Affairs AdPromo and Labeling, the Director, Regulatory Affairs Labeling, will be responsible for all labeling activities for approved products, as well as products in development that are nearing original submissions to the FDA and other health authorities. This role will also serve on the Promotional Review Committee (PRC) and the Medical Review Committee (MRC) for assigned activities. This individual will provide timely input to cross-functional teams responsible for reviewing labeling and promotional materials for Kiniksa’s products and will ensure effective communication with business partners and regulatory authorities.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities (including, but not limited to):
- 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
- Strong verbal and written communication skills
- High level of initiative and commitment
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Pay Range
$216,000—$232,000 USD
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.
