Develop Regulatory Strategies (US and Global) and implementation plans for identified projects in development and line extensions
Become knowledgeable with European Regulatory laws/guidances and provide strategic and operational advice to the regulatory group and the development teams -so that this position becomes the “ go-to “ position for this information.
Be the lead Regulatory person and provide interface for FDA and other regulatory authorities.on assigned projects
Working with the Submissions group, prepare and produce Regulatory Submissions for FDA and other RA's using internal & external resources.
Identify issues that will impact programs and provide strategies for dealing with them.
Provide advice to marketing group on labeling issues.
Act as regulatory representative on various cross-functional teams
Bachelors degree in scientific discipline; Advanced scientific degree preferred; Experience in Oncology Drug Development preferred.
5-10 years pharmaceutical industry experience, 7+ for Director (to include 5-7 years in reg affairs). Global experience desirable.
Thorough knowledge of the drug development process.
Specific expert knowledge in one or more key areas- Oncology Drug Development/CMC/pharmtox/biopharmaceutics/clinical/labeling
Inter-dependant partnering skills, team-orientated and ability to influence outcomes are necessary skills in the environment.
Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail
Domestic and occasional International travel may be necessary