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 develops and implements regulatory strategies and related leadership for assigned drug development and commercial projects. This role drives US and/or outside-US (OUS) regulatory submissions and health authority interactions and develops strategies to reduce risk and identify opportunities to accelerate development in line with corporate objectives and timelines. The Director combines strategic leadership with hands-on management, planning and coordination across early- and late-stage development and collaborates with internal and external stakeholders to execute program objectives in compliance with applicable regulations. The Director Regulatory affairs reports to the Executive Director, Regulatory Affairs and Writing. The Director provides Swiss-based input and direction to pipeline development, regulatory approval, and the maintenance of approvals and ongoing commercialization from a regulatory perspective.

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

Responsibilities (including, but not limited to):

Develop and implement regulatory strategies and related leadership for assigned drug development projects, driving US and/or OUS regulatory submissions, health authority interactions, and other regulatory requirements in line with corporate objectives and timelines.
Exercise delegated regulatory decision-making authority for assigned programs on behalf of the Swiss entity.
Coordinate and drive interactions with US and/or OUS health authorities for assigned drugs and programs, including preparing for and contributing regulatory positions at meetings, and coordinating responses and follow-up actions to facilitate timely review and approval of initial applications and subsequent submissions.
Assess regulatory risks and provide development and regulatory risk mitigation strategies to reduce risk and evaluate opportunities to accelerate development in a fast-paced environment.
Communicate the implications of regulatory options for clinical development, approval timelines, and applicable post-approval activities to relevant stakeholders.
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, and annual updates, as applicable.
For assigned approved products, own and oversee the regulatory strategy for lifecycle activities, including amendments, safety reports, annual updates, and responses to health authority requests, to support maintenance of regulatory approvals and ongoing commercialization from a regulatory perspective.
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 set regulatory strategies while taking a hands-on approach to all regulatory activities.
Strong leadership and communication skills, with the ability to work across multiple functional areas in a matrixed team environment.