Manager, Regulatory Affairs
SUMMARY: Manages the day to day CMC regulatory activities for one or more development and/or marketed projects and through this is responsible for achieving results that impact the success of the department and company.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):
- Manages several projects simultaneously with an emphasis on CMC while adapting to changing project priorities.
- Maintains all CMC aspects of US regulatory filings and clinical trial applications outside the US, ensuring that they remain compliant with all applicable regulations and relevant guidelines (domestic and international).
- Assists and provides guidance to other departments and submission authors, for the writing and editing of regulatory submissions, in compliance with departmental and regulatory standards.
- Produces high quality regulatory submissions appropriate for electronic publishing systems.
- Researches and provides analysis of current regulations and guidance.
- Expedites review and/or approval of submissions.
- Provides CMC regulatory support, guidance, and expertise to QA, QC, and Manufacturing teams; develop CMC regulatory strategies for product development, including technical documentation and change controls.
- Ensures the company is adhering to all applicable government regulations
- May be required to directly interface with US and international regulatory authorities on specific projects
- Participates in the project team meetings and offers advice pertinent to regulations.
- Responsible for assigned activities with the project team. Performs other duties as required.
Ability to work independently with minimal direction, including functional representation within project teams and committees in order to attain group goals.
Strong knowledge of FDA regulations, including current Good Manufacturing Practices.
Experience with electronic filing (eCTD), electronic document management systems and with document review and approval processes
Excellent verbal and written communication skills.
EDUCATION and/or EXPERIENCE:
Bachelor’s degree Life/Health Sciences. 3-5 years Regulatory Affairs experience in a pharmaceutical company with focus on CMC activities. Experience managing external contract services, and direct interaction with FDA.