The Director of Regulatory Affairs is expected to oversee and manage the broad regulatory obligations, expectations, strategic and execution needs of the company. They will work in collaboration with internal and external experts to assure planning, preparation and management of regulatory submissions. They will partner with the functional areas on various projects including CROs, CMO/development partners, and consultants in the planning, organizing, and preparing of regulatory strategy and documents for submission to governmental regulatory agencies. For the appropriate candidate, this role can also serve as primary liaison with regulators and can help build the regulatory department as the company grows. While this person may have a specific area of regulatory expertise (e.g. CMC, clinical…), responsibilities will extend across the entire regulatory portfolio with the help of consultants.
Act as liaison between Regulatory Affairs and other functional areas including 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, including Product Development Teams
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 clinical and CMC development strategy and implementation of regulatory strategy for assigned projects
Accountable for preparing, coordinating, and managing various regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, 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), and control and management of documents.
Provide thoughtful & accurate comments during document review (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.), mindful of regulatory/ICH guidance/requirements pertaining to document content.
Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.).
Provide regulatory support for CMC operations activities (e.g., strategy for process/analytical development, process control strategy, justification of specification, stability plan, review of essential technical documents, and development and review of CMC section, etc.).
Assure the timely development and submission of INDs. 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, and review and communicate current & emerging regulatory requirements.
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, Clinical, Quality Assurance or other departments.
Excellent communication and organization skills.
Able to handle multiple projects and exercise good judgment in prioritizing tasks.
Ability to evaluate and interpret regulatory documents and determine appropriate action
Ability to provide regulatory input to other departments on relevant topics and issues
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).
Working knowledge of project management tools, i.e. MS Project, Microsoft Timeline, Proficient with Microsoft Office applications, Adobe and document management templates.
Knowledge of all FDA requirements pertaining to the control and submission of regulatory documents for biologics/drug approval
Solid understanding of FDA regulations and ICH guidance’s and experience with 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
Demonstrated experience in FDA interaction and documentation preparation.
Minimum of a Bachelor’s degree in a scientific field; Advanced degree desirable
A minimum of 7 years of regulatory experience in a pharmaceutical/biologics company with demonstrated increasing expertise and responsibility.
Experience with biologics/vaccines and regulatory submissions related to cell and gene therapy, or personalized drugs is preferred
Domestic travel may be required