about 1 month ago
The Manager, Regulatory Affairs is responsible for leading and contributing to all regulatory activities for this client's product pipeline, including new gene therapy products, vaccines, and other biological products, to ensure alignment and compliance with local and international registration requirements as well as with company policies. This position reports directly to the SVP, Regulatory Affairs.
Duties and responsibilities
· Work with a team to develop and implement strategies for timely submission and approval of regulatory submissions which include pre-IND and other milestone meetings with regulatory agencies
· Coordinate with internal and external teams to draft and author pre-clinical submissions, INDs, Clinical trial protocols, marketing applications, and other as needed regulatory applications, etc.
· Represent Regulatory Affairs in internal and external (vendor) meetings
· Coordinate with third party submission group to file applications via gateway submissions and establish timelines
· Provide leadership as required internally and externally regarding quality interpretation of regulatory requirements
· Lead and support various Regulatory Affairs and cross-functional activities/projects, as needed
· Ensures timely preparation of organized and scientifically valid applications
· Provides expertise in translating regulatory requirements into practical, workable plans
· Interacts with regulatory agencies.
· Selects, develops, and evaluates personnel to ensure the efficient operation of the function
· BS in life sciences or related field required
· 5+ years of relevant and current work experience in pharmaceutical regulatory required
· Knowledge of manufacturing, clinical and analytical services in the pharma industry, vaccine and/or gene therapeutic regulatory knowledge preferred
· Solid and demonstrable knowledge of GMP, GLP and GCP international regulations
· Proven background in risk and regulation management, mitigation, and compliance
· Strong organization and time management skills
· Attention to detail with an ability to perform critical review of various types of documents
· Outstanding communication and writing skills
· Demonstrated ability to work as a team player on multi-disciplinary project teams