Regulatory Affairs Director
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 an experienced individual to direct the Regulatory Affairs Unit of the Clinical Trials area.
- Plan and manage interactions and communications related to ongoing regulatory projects.
- Oversight of IND development and maintenance and eCTD submission.
- Oversight of the maintenance of electronic Trial Master Files and SOP review and compliance.
- Maintain consistent oversight of deliverables in accordance with FDA guidance, policies and procedures.
- Identify and assess regulatory risks.
- Interface, communicate, and coordinate with the FDA and other regulatory agencies on submissions, approvals, or other related issues.
- Collaborate with the project teams and contribute to business development.
- A bachelor’s degree in life science or health with a minimum of 8 years’ experience in regulatory affairs across multiple phases of drug development in various disease areas is required.
- 3 years of experience with eCTD submissions and/or pharmacovigilance management is required.
- Knowledge of Federal regulations, and FDA, ICH/GCP, and OHRP guidelines is required.
Demonstrated leadership in regulatory capacity-building and in mentoring and supervising staff who perform domestic and international regulatory submissions is essential. The successful candidate will work with a goal-oriented team and possess strong organizational, written and oral communication skills. Strong technical skills is desirable.