Job Description
The Director, Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs in line with business objectives, and in coordination with key internal stakeholders. This individual will manage regulatory aspects of investigational agents in clinical development and provide leadership and strategic regulatory oversight and ensure that the latest requirements, guidance and standards are met. The individual will support the interface with regulatory agencies and business partners regarding development, regulatory, and registration strategies. The individual should also have experience with the development, implementation and maintenance of quality assurance systems and activities. This position will report to the Chief Medical Officer.
- Develop regulatory strategies to meet business objectives and ensure compliance with regulatory requirements
- Prepare and submit regulatory filings eg IB, annual reports, DSUR with the FDA
- Manage the daily operations of regulatory affairs and assure regulatory submission compliance and serve as regulatory authority liaison in connection with regulatory submissions, approvals, and audits
- Responsible for the Document Control process and the efficient control of all documentation required by regulatory agencies
- Review and interpret regulatory rules as they relate to company products and processes including product labeling
- Knowledge of IVD regulations and guidance’s, especially those relevant to Companion Diagnostics is a plus
- Management and oversight of quality operations, quality control, supplier quality management, document control, training, internal audits and CAPA subsystems
- Promote awareness of regulatory compliance and customer requirements throughout the organization and collaborate with other departments to ensure compliance quality requirement
- Ensures departmental training and compliance with established regulations, guidance’s and develop SOPs related to regulatory affairs and Q
- Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies changes on company pipeline strategy
- Be up to date with regulatory affairs and FDA guidance
Job Requirements
- Minimum of 8 years of managing Regulatory Affairs and Quality Assurance
- Experience with FDA and global biologics filings, IND, Pre-IND submissions
- Knowledge of applicable US FDA regulations, ICH Guidelines, other industry standards
- Quality Assurance experience preferred (i.e. – managing and tracking deviations, CAPAs, Change Control, Training/Personnel records and systems, QA controlled documents, etc.)
- Experience in early drug development stage CMC activities is a plus
- Team player with strong attention to detail, timelines; able to maintain the confidentiality and security of sensitive material; strong interpersonal, time management, and organizational skills; adapts easily to changing priorities; able to work independently
- Must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups
