Lead regulatory activities for novel biologics and drugs from pre-IND and nonclinical stages through to clinical development and marketing applications. Develop regulatory strategies, manage complex submissions, and coordinate interactions with regulatory authorities like the FDA.
The Director, Regulatory Affairs will serve as the primary Regulatory Lead for infectious disease biologics programs, overseeing global regulatory strategy, submissions, and health authority interactions from early development through clinical stages. This role involves leading cross-functional regulatory efforts, assessing risks, and ensuring compliance with all relevant regulatory requirements.
