Senior Clinical Trials Area Regulatory Specialist
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.
Westat is seeking a Senior Clinical Trials Area Regulatory Specialist to help lead our regulatory team with a focus on electronic Common Technical Document submissions.
Responsibilities include, but are not limited to: leading and coordinating the preparation of regulatory submissions to FDA, including INDs, NDAs, BLAs, materials for formal meetings with the FDA, and others, ensuring compliance with the electronic Common Technical Document (eCTD) specifications. Experience preparing IND, BLA, and/or NDA filings and leading successful negotiations with FDA is required.
· A master's degree in science or other health-related field
· 10 years of experience with clinical trials and regulatory submissions in the FDA regulated industry
· Expert knowledge of US Federal regulations ICH guidelines for Good Clinical Practices, and the regulatory requirements and specifications of eCTD.
· Must have experience with successful preparation and filing of IND and NDA/BLA submissions in eCTD
The qualified candidate must possess strong and dynamic management skills, the ability to prioritize multiple regulatory submissions, strong oral and written communication skills, excellent attention to detail, managing and adhering to timelines, and the ability to work and collaborate closely with all departments.
Westat offers competitive benefits with ESOP, 401k, Health, Dental, paid vacation, sick and holiday leave, professional development as well as other benefits.
Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the position, based on the specific position which may include, for example, identity verification, employment history, or criminal records history.
Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by Federal, state, or local law.