Director, Regulatory Affairs - US & OUS Strategy for Biologics

Kiniksa Pharmaceuticals; Zürich; On-site; CHF 211,000 - 231,000; Full time

Job summary

Kiniksa Pharmaceuticals, a leading biopharmaceutical company, seeks a Director, Regulatory Affairs to lead US and OUS regulatory submissions and health authority interactions. Based in Switzerland, the role combines strategic oversight with hands-on support across development and post‑approval lifecycle management.

Required: BS degree, 10+ years in Regulatory Affairs; US/OUS submission experience; German fluency; strong leadership and communication skills to work in a matrixed team.

Qualifications

• BS degree required; PharmD or PhD preferred; minimum 10 years Regulatory Affairs experience.
• Experience supporting US and/or OUS regulatory submissions (BLAs/MAAs) and post‑approval lifecycle activities.
• Experience preparing regulatory submissions including CTAs, safety reports, Investigator Brochures and DSURs.
• Fluency in German language.

Responsibilities

• Provide strategic regulatory leadership for drug development and commercial programs for US and/or OUS submissions.
• Exercise delegated regulatory decision‑making authority for Swiss entity programs.
• Support interactions with US and/or OUS health authorities and prepare for meetings to facilitate reviews.
• Develop regulatory strategies to accelerate development and support post‑approval lifecycle objectives.
• Lead and support regulatory submissions planning across trials, safety reports, amendments, and variances.
• Communicate regulatory expectations to internal and external stakeholders to ensure compliance.
• Develop policies and best practices for a rapidly growing company.

Skills

Regulatory leadership

Cross-functional collaboration

Strategic thinking

Regulatory communication

Team adaptability

Education

BS degree

PharmD or PhD preferred

Tools

eCTD

e-publishing systems

Job description

Kiniksa Pharmaceuticals, a leading biopharmaceutical company, seeks a Director, Regulatory Affairs to lead US and OUS regulatory submissions and health authority interactions. Based in Switzerland, the role combines strategic oversight with hands-on support across development and post‑approval lifecycle management.

Required: BS degree, 10+ years in Regulatory Affairs; US/OUS submission experience; German fluency; strong leadership and communication skills to work in a matrixed team.