The Sr. Manager will focus on regulatory activities for late stage vaccine product and will support early stage (Pre-IND) products, as necessary. This person will serve as a regulatory representative on Product Development Teams and provide CMC regulatory strategy and guidance for a Phase 3 product in preparation for a BLA. They will provide authoring, review, and coordination for quality submissions to regulatory agencies. They will also prepare for meetings, teleconferences, and other communications (including pre-read packages and/or other necessary documentation) with FDA. They will educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.
Major Responsibilities and Duties:
* Develop and effectively communicate regulatory strategies for a Phase 3 vaccine
* With minimal supervision, plan and manage CMC regulatory activities related to assigned projects.
* Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions.
* Manage the preparation, including writing, assembly, review, and timely submission of regulatory dossiers as required for an IND and BLA registration
* Lead the strategy and preparation of briefing packages for formal meetings with the FDA (Type C and Pre-BLA Meetings)
* Provide critical technical and regulatory review of all documentation supporting regulatory applications
* Plan, coordinate, prepare and lead meetings and teleconferences with regulatory agencies
* Provide regulatory guidance to project teams and prepare product development plans
* Work closely with Regulatory Operations for timely submission of electronic and paper submissions.
* Ensure FDA commitments are met in a timely manner.
* Interact with company partners and consultants for various regulatory matters as needed
* Interact with business divisions, other functional managers, and internal/external customers
* Monitor applicable current and new regulatory requirements
* Assume other duties as assigned.