Description
DescriptionA fast growing, phase III pharmaceutical company seeking a Senior Regulatory Affairs Manager to join their growing team in the San Francisco Bay Area.
Responsibilities
- Reporting to the head Regulatory Affairs, you will be responsible for the successful execution of multiple projects and provide leadership to associate directors, managers and regulatory affairs team
- OverseeNDA,IND, CTA maintenance and the submission of amendments
- Oversee the development of plans incorporating regulatory strategies designed to maximize chances of successful registration.
- Support planning, preparing, and submission ofIND's and NDA's
- Manage interactions with FDA or other regulatory authority bodies
- Manage the planning and implementation of meetings with regulatory agencies
- Act as primary regulatory agency contact for assigned projects
Required Experience
- Minimum five years pharmaceutical industry and/or regulatory agency experience withIND, NDA and Ex-US submissions.
- Team management experience a plus
- Experience in dealing with regulatory agencies acrossEU,USAand emerging markets.
- Develops technical and/or business solutions to complex problems.
To find out more about Real please visit www.realstaffing.com