Director US Regulatory Affairs

As the US Director of Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies to advance a portfolio of anti-infective products through various stages of development.

A key focus will be co-leading the New Drug Application (NDA) for the most advanced product in collaboration with cross-functional teams.

This role involves translating regulatory requirements into actionable plans, facilitating meetings with regulatory authorities, and guiding project teams.

The position is remote, based in the US, with collaboration across international teams, primarily in Europe. The US Director will report directly to the Vice President of Regulatory Affairs and be part of a dynamic and agile regulatory team.

Key Responsibilities :

• Lead or co-lead the preparation and submission of NDAs in the US, including dossier preparation, FDA interactions, and responses to regulatory questions.
• Post-approval, ensure ongoing compliance with local regulatory requirements.
• Serve as the main point of contact for the FDA across the product portfolio.
• Develop clinical regulatory plans and strategies, identify risks, and propose mitigation strategies for project teams across multiple international locations.
• Plan, coordinate, and oversee submissions to the FDA for assigned projects and products.
• Provide strategic and hands-on regulatory support for the company’s compounds and potential line extensions.
• Conduct regulatory assessments during due diligence processes.
• Maintain up-to-date knowledge of complex regulatory requirements and communicate changes to internal teams.
• Contribute to developing internal regulatory policies and procedures, driving best practices and efficient work processes.

Qualifications :

• Advanced academic degree in a natural science field.
• Minimum of 10 years of regulatory experience within the pharmaceutical or biotech industry, including direct experience leading a US-based NDA.
• Proficiency in preparing and submitting regulatory documents (INDs, NDAs) to US regulatory authorities.
• Strong ability to identify and assess regulatory risks, develop mitigation strategies, and ensure compliance.
• Familiarity with OPDP requirements and post-marketing regulatory experience is a plus.
• Experience in antiviral or anti-infective therapeutic areas is beneficial.
• Strong organizational, communication, and intercultural skills, with the ability to work collaboratively across teams.
• Proven leadership skills, with the ability to motivate multidisciplinary teams and drive results in a fast-paced environment.
• Commitment to innovative thinking, operational excellence, and adapting to complex situations.

Why Join Us?

This role offers a unique opportunity to work in a collaborative and innovative environment. The company is committed to scientific excellence, translating research into commercial success, and improving patient lives.

You’ll have opportunities for personal and professional growth, with access to development and learning programs. Flexibility in working arrangements ensures a healthy work-life balance.

Additionally, the company offers a competitive benefits package.