Director-Advanced Drug Delivery - WYEYH-US- Andover-MA-United States
Job Responsibilities
This position oversees the development of advanced delivery systems for BioPharma compounds from early development to registration and launch. Establishes processes for optimizing drug product development process setting development strategy and adherence to timelines. Ensures capture of intellectual property.
Involved in setting drug product regulatory strategy and implementation. Provides functional review of regulatory filings and sets strategy for addressing questions from regulatory bodies. Provides subject matter expertise for presentation to global regulatory bodies.
Provides opportunities for commercial product line extensions and enhancements. Works closely with Business Unit leadership to set LCM development strategy and establishes budget requirements. Provides technical guidance and project accountability.