Director, Regulatory Affairs

About the role

Kiniksa Pharmaceuticals, a biopharmaceutical company focused on cardiovascular indications, is hiring a Director, Regulatory Affairs. The role reports to the Executive Director, Regulatory Affairs and Writing (US based) and provides strategic regulatory leadership for drug development and commercial programs, supporting US and/or outside-US regulatory submissions and health authority interactions. It is based in Switzerland.

Key responsibilities

• Provide strategic regulatory leadership for assigned drug development and commercial programs, including US and/or OUS submissions, health authority interactions and lifecycle management.
• Exercise delegated regulatory decision-making authority for assigned programs on behalf of the Swiss entity.
• Support interactions with US and/or OUS health authorities, including preparing for and contributing to meetings to speed up review and approval.
• Develop regulatory strategies to reduce risk, accelerate development and support post-approval changes and lifecycle objectives.
• Lead and support the regulatory team in preparing US and/or OUS submissions, including clinical trial applications (INDs, CTAs), marketing applications (BLAs, MAAs), drug master files, amendments, safety reports, annual updates, post-approval supplements and variations, and renewals.
• Interpret and communicate regulatory expectations to internal and external stakeholders.
• Develop policies, procedures and best practices suited to a rapidly growing company.

Required profile

• BS degree required; PharmD or PhD preferred.
• Minimum of 10 years of Regulatory Affairs experience in the biopharmaceutical industry.
• Prior experience supporting US and/or OUS marketing application submissions (BLAs, MAAs) and post-approval activities across early- and late-stage development.
• Experience preparing regulatory documents such as clinical trial applications, safety reports, Investigator Brochures, DSURs and briefing packages.
• Experience interacting with US and/or OUS health authorities and working in a matrixed team.
• Fluency in German.
• Biologics drug development experience highly desirable; immunology/inflammation experience a plus.

Required skills

• Strong knowledge of US and/or OUS regulatory requirements for clinical development, marketing applications and post-approval lifecycle.
• Hands-on approach to regulatory activities, with strong leadership, communication and strategic thinking.
• Familiarity with eCTD and e-publishing systems is a plus.

The pay range is CHF 210,800 - CHF 231,000.