The Director, Regulatory Affairs, reports to the Executive Director, Regulatory Affairs and Writing (US based) and provides strategic regulatory leadership for drug development and commercial project(s)/program(s). This role supports 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 support across early- and late-stage development and post-approval lifecycle management and collaborates with internal and external stakeholders to execute program objectives in compliance with applicable regulations.

This role is based in Switzerland.

Responsibilities (including, but not limited to):

• Provide strategic regulatory leadership for assigned drug development and commercial programs, supporting US and/or OUS regulatory submissions, health authority interactions, and lifecycle management activities in line with corporate objectives and timelines.
• 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 facilitate timely review and approval of initial applications and subsequent submissions.
• Develop regulatory strategies to reduce risk, identify opportunities to accelerate development, and support post-approval changes and lifecycle objectives for marketed products.
• 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, annual updates, post-approval supplements and variations, renewals, and other lifecycle maintenance submissions, as applicable.
• 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.
• Strategic thinking that balances near-term objectives with long-term goals and outcomes.
• Strong verbal and written communication skills, including the ability to clearly articulate regulatory viewpoints to a diverse audience.
• Ability to thrive in a collaborative and fast-paced team environment.

Qualifications and Experience:

• BS degree required; PharmD or PhD preferred. A minimum of 10 years of Regulatory Affairs experience within the biopharmaceutical industry is required.
• Strong knowledge of regulatory requirements supporting clinical development, marketing applications, and post-approval lifecycle management in the US and/or OUS markets.
• Prior experience successfully supporting US and/or OUS marketing application submissions (e.g., BLAs and MAAs) and post-approval regulatory activities, with experience across early- and late-stage development and commercial product lifecycle management.
• Experience preparing and supporting US and/or OUS regulatory submissions, including clinical trial applications, safety reports, Investigator Brochures, DSURs, briefing packages, and other regulatory documents as required.
• Experience supporting interactions with US and/or OUS health authorities.
• Experience working with multiple functional areas in a matrixed team environment is required.
• Experience with biologics drug development is highly desirable; experience in immunology/inflammation is a plus.
• Familiarity with eCTD and e-publishing systems for preparing regulatory submissions is a plus.
• Fluency in German Language.