Director, Regulatory Affairs — Global Strategy & Submissions

Kiniksa Pharmaceuticals; Zug; Presencial; CHF 211.000 - 231.000; Jornada completa

Descripción de la vacante

Kiniksa Pharmaceuticals, a biopharmaceutical company focused on cardiovascular indications, seeks a Director of Regulatory Affairs based in Switzerland. This leadership role drives regulatory strategy for drug development and commercial programs, coordinating US and/or OUS submissions and health authority interactions.

You will lead a team, interact with global regulators, and shape lifecycle management strategies while ensuring compliance with applicable regulations.

Formación

• .BS degree required; PharmD or PhD preferred; minimum 10 years in Regulatory Affairs in biopharma.
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Responsabilidades

• Provide strategic regulatory leadership for drug development and commercial programs (US and/or OUS) and lifecycle management.
• Exercise delegated regulatory decision-making authority for Swiss entity.
• Support interactions with US and/or OUS health authorities and prep for meetings to facilitate timely submissions.
• Develop regulatory strategies to reduce risk and accelerate development for marketed products.
• Lead and support regulatory submissions (INDs/CTAs, BLAs/MAAs, safety reports, DSURs, etc.).
• Interpret regulatory expectations for internal/external stakeholders and promote best practices.

Conocimientos

Regulatory leadership

Cross-functional leadership

Strategic thinking

Verbal and written communication

Team collaboration

Educación

Bachelor's degree

PharmD or PhD preferred

Herramientas

eCTD/e-publishing

Descripción del empleo

Kiniksa Pharmaceuticals, a biopharmaceutical company focused on cardiovascular indications, seeks a Director of Regulatory Affairs based in Switzerland. This leadership role drives regulatory strategy for drug development and commercial programs, coordinating US and/or OUS submissions and health authority interactions.

You will lead a team, interact with global regulators, and shape lifecycle management strategies while ensuring compliance with applicable regulations.