Director, Regulatory Affairs

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.

The Director, Regulatory Affairs is a regulatory strategist who develops and implements global regulatory strategies and provides regulatory leadership for assigned drug development programs, including potentially serving as regulatory lead for a development program (e.g., a newly in-licensed asset). The role also provides regulatory oversight of the commercial product. Demonstrated regulatory experience across both the US and outside-US (OUS) markets, including exposure to the US FDA, is required, including experience supporting regulatory submissions and interactions with health authorities in both regions.

The Director combines strategic leadership with hands-on execution, planning, and coordination across early- and late-stage development, identifying regulatory risks and opportunities, and partners closely with internal and external stakeholders to advance program objectives.

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

Responsibilities (including, but not limited to):  

• Develop and implement global regulatory strategies for assigned drug development programs in alignment with corporate objectives and timelines, and serve as regulatory lead for assigned development programs, including newly in-licensed assets, as needed.
• Exercise delegated regulatory decision-making authority for assigned programs on behalf of the Swiss entity.
• Coordinate and lead interactions with US and OUS health authorities, including developing regulatory positions, preparing for meetings, and coordinating responses and follow-up actions to support timely review and approval of initial applications and subsequent submissions.
• Develop regulatory strategies to reduce risk and identify opportunities to accelerate development.
• Commercial product: Provide regulatory oversight of the commercial product, including post-approval changes, labeling and lifecycle objectives, and health authority interactions.
• Provide leadership and hands-on support to the regulatory team in managing, planning, coordinating, and preparing US and/or OUS regulatory submissions, including clinical trial applications (e.g., INDs and CTAs), marketing applications (e.g., BLAs and MAAs), drug master files, amendments, safety reports, annual updates, post-approval supplements and variations, renewals, and other lifecycle maintenance submissions, as applicable.
• Interpret and communicate regulatory expectations to internal and external stakeholders to execute program objectives in compliance with applicable regulations.
• Strategic leadership and development of policies, procedures, and best practices commensurate with the requirements of a rapidly growing company.

Standout Skills for Impact: 

• Ability to establish and execute integrated US and OUS regulatory strategies while maintaining a hands-on approach to regulatory activities
• Strong leadership and verbal and written communication skills, including the ability to clearly articulate regulatory viewpoints to a diverse audience and work across multiple functional areas.
• Strategic thinking that balances near-term objectives with long-term goals and outcomes.

Qualifications and Experience:  

• Demonstrated regulatory experience in both the US and OUS markets, including exposure to the US FDA, is required, with strong knowledge of regulatory requirements supporting clinical development and marketing applications across both regions.
• Prior experience successfully supporting marketing application submissions (e.g., BLAs and MAAs) and post-approval regulatory activities, with experience across early- and late-stage development and commercial product lifecycle management, including regulatory oversight of a marketed product.
• Experience preparing and supporting regulatory submissions, including clinical trial applications, safety reports, Investigator Brochures, DSURs, briefing packages, and other regulatory documents as required.
• Experience supporting interactions with health authorities.
• Experience working with multiple functional areas in a matrixed team environment is required.
• Experience with biologics drug development is highly desirable; experience in immunology/inflammation is a plus.
• Familiarity with eCTD and e-publishing systems for preparing regulatory submissions is a plus.
• Fluency in German Language.

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.