Director, CMC Regulatory Affairs

Our clinical-stage Vaccine client here in Boston, MA is growing and looking to add a Director, CMC Regulatory Affairs (REMOTE) to their team! Role will be accountable for the preparation and management of CMC focused regulatory submissions. Will act as key regulatory partner with other functional areas including external CROs/ partners and lead the planning, organizing, and preparing of CMC regulatory documents for submission to governmental regulatory agencies. 

  • Lead the regulatory affairs input to all CMC related development plans, including the QTPP, change control processes, methods development and validation, process changes from phase 2 to commercial, including site transfers and comparability protocol development.   
  • Establish leadership across industry working groups and with regulatory agencies to advance vaccine manufacturing goals.
  • Provide critical regulatory input to other functional areas including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies. Represent Regulatory Affairs in cross-functional team meetings.
  • Responsible for managing regulatory compliance, identifying regulatory issues relevant to products in development and providing accurate and timely recommendations to management and Project Teams.
  • Actively contribute to the CMC development plans, and implement the regulatory strategy.
  • A comprehensive knowledge of US and international regulations, cGMP and assay requirements for biologics.
  • Preparing, coordinating, and managing various regulatory submissions (e.g., INDs, CTAs, amendments, CMC sections of 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).
  • Acts as the regulatory project manager for IND and BLA/NDA document preparation for all CMC related FDA submissions to CBER. 
  • Liaise with CROs to prepare CMC content of submissions in Europe/Latam/Asia.
  • Provide thoughtful & accurate comments during document review (e.g., CMC modules, CTAs, annual reports, etc.), mindful of regulatory/ICH guidance/requirements pertaining to document content.
  • Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of CMC regulatory submissions. 
  • Monitor company progress toward fulfillment of CMC regulatory commitments.
  • Manage Regulatory Timelines and submission requirements for CMC aspects 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, Manufacturing, Quality Assurance or other departments. 
  • Review and communicate current & emerging regulatory requirements (US and international regulations and guidelines). 

Requirements:

  • Minimum of a Bachelor’s degree in a Science Field; Advanced degree in a Science field desirable.
  • A minimum of 7 years’ of regulatory experience in a pharmaceutical/biologics company with demonstrated increasing expertise and responsibility in the CMC regulatory area.  Experience with biologics/vaccines preferred.
  • Knowledge of all FDA requirements pertaining to the content and submission of CMC regulatory documents for biologics/drug approval.
  • Well developed knowledge of cGMP practices as applicable to formulation, analytical development, technology transfer, manufacturing and release of vaccines or a biologic.
  • Solid understanding of FDA regulations and ICH guidance and experience with CMC 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 vaccines.
  • Domestic and international travel may be required.
  • Proven experience in a matrix environment is preferred.
  • Demonstrated ability to work efficiently across multiple project teams and business functions.
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks. 
  • The 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). 
  • Excellent verbal and written communication skills
  • Ability to evaluate regulatory documents and determine appropriate action
  • Ability to actively provide regulatory input to other departments (e.g. CMC) on relevant topics and issues

Travel, Physical Demands & Work Environment:

  • Willingness to travel to various meetings or client sites, including overnight trips.  Some international travel may be required.
  • Up to 20-25%