Our clinical-stage Vaccine client here in Boston, MA is growing and looking to add a Sr. Director, Regulatory Affairs (REMOTE) to their team! Role will be accountable for the preparation and management of clinically focused regulatory submissions. Will lead development of the Global Regulatory Strategy document for the product, establish leadership across industry working groups and with regulatory agencies and provide critical regulatory input to other functional areas focused on the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies. Other responsibilities include but not limited to:
- Actively represent Regulatory Affairs input at cross-functional team meetings.
- Responsible for managing regulatory strategy, identifying regulatory issues relevant to products in development and providing accurate and timely recommendations to management and Project Team(s).
- Actively contribute to the clinical development plans, and implement the regulatory strategy.
- Comprehensive knowledge of US and international regulations and GxP standards.
- Prepare, coordinate and manage various regulatory submissions (INDs, CTAs, amendments, annual reports, meeting packages, etc.) in accordance with applicable regulations. This includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
- Act as the regulatory project manager for IND and BLA/NDA document preparation for all clinical related FDA submissions to CBER.
- Liaise with CROs to prepare content of submissions in Europe/Latam/Asia.
- Provide thoughtful & accurate comments during document review (eCTD modules, CTAs, annual reports, etc.), mindful of regulatory/ICH guidance/requirements pertaining to document content.
- Interface with external regulatory groups (CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of clinical regulatory submissions.
- Monitor company progress toward fulfillment of regulatory commitments.
- Manage Regulatory Timelines and submission requirements in order to provide metrics to senior management.
- Track and evaluate changes to regulatory requirements and guidelines as they impact development of our products.
- Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.
- Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, or other departments.
- Review and communicate current & emerging regulatory requirements (US and international regulations and guidelines).
- Minimum of a Bachelor’s degree in a Science Field; Advanced degree in Science desirable
- A minimum of 10 years’ of regulatory experience in a pharmaceutical/biologics company with demonstrated increasing expertise and responsibility in the overall regulatory area, with a focus on strategy
- Experience with biologics/vaccines is preferred
- Knowledge of all FDA requirements pertaining to the content and submission of CMC regulatory documents for biologics/drug approval
- Well developed knowledge of GCP practices and clinical trial designs
- Solid understanding of FDA regulations and ICH guidance, and experience with CTA and/or BLA regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format
- A working knowledge of FDA and regulations relevant to the development and approval of new therapeutic agents, biologics and/or vaccines
- Able to handle multiple projects and exercise good judgment in prioritizing tasks
- Ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (vendors, investigators, regulatory authorities, and other stakeholders)
- Willingness to travel domestically (20-25%) to various meetings or client sites, including overnight trips.
- Some international travel may be required.