The Associate Director of Regulatory Affairs is accountable for the preparation and management of simple and complex regulatory submissions. They will act as liaison between Regulatory Affairs and other functional areas on various projects including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies.
- Act as liaison between Regulatory Affairs and 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, 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 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)
- 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.
- Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
- Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.).
- Monitor company progress toward fulfillment of regulatory commitments.
- Assure the timely development and submission of INDs; control and management of documents.
- Manage Regulatory Timelines and submission requirements in order to provide metrics to senior management.
- Managing progress of regulatory filings and overall tracking of regulatory strategy against the project timelines.
- 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, Clinical, Quality Assurance or other departments.
- Review and communicate current & emerging regulatory requirements (e.g., US and international regulations and guidelines).
- Able to handle multiple projects and exercise good judgment in prioritizing tasks.
- Excellent organization skills
- Proficient with Microsoft Office applications, Adobe and document management templates.
- 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, etc.
- Excellent verbal and written communication skills
- Ability to evaluate regulatory documents and determine appropriate action
- Ability to provide regulatory input to other departments on relevant topics and issues
Education and Experience Required
- 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 preferred.
- 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
- Domestic travel may be required