Opportunity Details

The client is seeking a Director of US Regulatory Affairs to support the Global Therapeutic Area Lead in developing and executing regulatory strategies for antimicrobial/antifungal programs globally or within specific regions. The ideal candidate will have a Bachelor's degree in a scientific discipline, 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, and strong knowledge of regional regulatory requirements and guidelines. Responsibilities include preparing regulatory documents, maintaining project timelines, organizing meeting minutes, conducting research on regulatory trends, and providing regulatory guidance for post-marketing activities.

Specific projects for the Director of US Regulatory Affairs include preparing regulatory submissions, contributing to regulatory strategy plans, and aligning regional strategies with global development plans. Performance will be monitored through regular reviews by the Global Therapeutic Area Lead, with metrics including completion of regulatory submissions, adherence to timelines, and submission quality. The Director will also assist in managing regulatory risks, developing mitigation strategies, and providing regulatory support for post-marketing activities related to marketed anti-infectives.

Additional responsibilities for the Director of US Regulatory Affairs include preparing regulatory updates, progress reports, and strategic recommendations for senior leadership. This role will involve gathering regulatory intelligence, drafting regulatory documents, creating visual summaries, and maintaining a library of past regulatory data for reference and audits. The ideal candidate will have excellent communication and interpersonal skills, as well as the ability to work effectively in a cross-functional team environment.