Director, Regulatory Affairs

The Director, Regulatory Affairs develops and implements regulatory strategies and related leadership for assigned drug development and commercial projects. This role drives 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 management, planning and coordination across early- and late-stage development and collaborates with internal and external stakeholders to execute program objectives in compliance with applicable regulations. The Director Regulatory affairs reports to the Executive Director, Regulatory Affairs and Writing. The Director provides Swiss-based input and direction to pipeline development, regulatory approval, and the maintenance of approvals and ongoing commercialization from a regulatory perspective.

This role is based in Zug, Switzerland and requires employees to be onsite five days per week.

Responsibilities (including, but not limited to):  

• Develop and implement regulatory strategies and related leadership for assigned drug development projects, driving US and/or OUS regulatory submissions, health authority interactions, and other regulatory requirements in line with corporate objectives and timelines.
• Exercise delegated regulatory decision-making authority for assigned programs on behalf of the Swiss entity.
• Coordinate and drive interactions with US and/or OUS health authorities for assigned drugs and programs, including preparing for and contributing regulatory positions at meetings, and coordinating responses and follow-up actions to facilitate timely review and approval of initial applications and subsequent submissions.
• Assess regulatory risks and provide development and regulatory risk mitigation strategies to reduce risk and evaluate opportunities to accelerate development in a fast-paced environment.
• Communicate the implications of regulatory options for clinical development, approval timelines, and applicable post-approval activities to relevant stakeholders.
• 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, and annual updates, as applicable.
• For assigned approved products, own and oversee the regulatory strategy for lifecycle activities, including amendments, safety reports, annual updates, and responses to health authority requests, to support maintenance of regulatory approvals and ongoing commercialization from a regulatory perspective.
• 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. 10 - 15 years of Regulatory Affairs experience within the biopharmaceutical industry is required.
• Strong knowledge of regulatory requirements supporting clinical development and marketing applications in the US and/or OUS markets.
• Prior experience successfully supporting US and/or OUS marketing application submissions (e.g., BLAs and MAAs), with experience in both early- and late-stage drug development.
• 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.