Senior Director, Global Regulatory Strategy & Submissions

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

Job summary

Kiniksa Pharmaceuticals, a commercial‑stage biopharmaceutical company, is seeking a Director, Regulatory Affairs based in Switzerland. This role leads strategic regulatory activities for drug development and lifecycle management across US and OUS, with authority for Swiss submissions and interactions.

Fluency in German is required for collaboration across markets. You will shape regulatory strategies, liaise with authorities, and guide a cross‑functional team to ensure timely approvals and

Qualifications

• BS degree required; PharmD or PhD preferred.
• Extensive regulatory affairs experience in biopharma (≥10 years).
• Experience with US and/or OUS marketing applications (BLAs/MAAs) and lifecycle management.
• Familiarity with regulatory submissions, safety reports, DSURs, and Investigator Brochures.
• Fluency in German language.

Responsibilities

• Provide strategic regulatory leadership for drug development and commercial programs, supporting US and/or OUS submissions and health authority interactions.
• Exercise delegated regulatory decision‑making authority for Swiss entity.
• Support interactions with health authorities and meetings to facilitate reviews and approvals.
• Develop regulatory strategies to reduce risk and identify opportunities to accelerate development.
• Lead and support regulatory submissions, including INDs/CTAs, BLAs/MAAs, and post‑approval variations.
• Interpret regulatory expectations for internal/external stakeholders to ensure compliant program objectives.
• Develop policies, procedures, and best practices for a rapidly growing company.

Skills

Regulatory strategy

Leadership

Cross‑functional collaboration

Verbal & written communication

German language

Education

BS degree

PharmD or PhD preferred

Tools

eCTD

e-publishing

Job description

Kiniksa Pharmaceuticals, a commercial‑stage biopharmaceutical company, is seeking a Director, Regulatory Affairs based in Switzerland. This role leads strategic regulatory activities for drug development and lifecycle management across US and OUS, with authority for Swiss submissions and interactions.

Fluency in German is required for collaboration across markets. You will shape regulatory strategies, liaise with authorities, and guide a cross‑functional team to ensure timely approvals and