The Regulatory Liaison will be a Regulatory member of our core development team. He/she will be
mentored by senior regulatory professionals to become proficient in the interactions with US and RoW
health authorities and working in cross-functional development teams.
· Assist in development of global regulatory strategies to ensure high likelihood of success of submissions/approvals
· Help liaise and assist with global regulatory authorities to manage day-to-day communications and operations
· Contribute to the clinical development plans and regulatory strategic plans, to the project team
· Assist the preparation of regulatory submissions including pre-IND and formal meeting requests with FDA, Annual reports and routine correspondence
· Assist in the planning, coordination and preparation for meetings and teleconferences with regulatory authorities
· Monitor and oversees clinical trial activities for regulatory compliance and practices
· Assist in providing regulatory intelligence for cross-functional project teams
· Assist in regulatory review, feedback and /or approval for relevant documents.
· Provide regulatory support and guidance to cross-functional project teams for regulatory issues and questions and ensure that regulatory requirements are addressed
· Interact with company partners and consultants for various regulatory matters as needed
· Coordinate timely submissions to FDA and other health authorities
· Assist with logging, tracking and filing of correspondence and submission to/from regulatory authorities
· Prepare and writes regulatory documents for submissions
· Monitor applicable current and new regulatory requirements
· Help to prepare plan and internal SOP’s to manage regulatory compliance and reporting requirements.
· B.Sc or M.Sc. in relevant field and at least 3 years of overall experience in the pharmaceutical industry. Advanced degree (PhD, PharmD) is a plus.
· Good working knowledge of FDA regulatory requirements and IND applications, experience in Pharmacovigilance is a plus
· Experience with multiple Health Authorities (FDA, EMA, PMDA) interactions and Scientific Advice proceedings
· Ability to assume accountability for a project goal/objective
· Experience working in cross-functional teams, participating in team discussions to resolve and reach agreement on project issues
· Excellent written and oral communication skills
· Knowledge in CNS disease area and Orphan Diseases is preferred
· Travel: Approximately 10% domestic and international travel for meetings with health authorities and conferences
Pre Clinical Development
Diseases And Disorders