Director – Regulatory Strategy

Bachelor’s degree in scientific discipline; advanced scientific degree preferred (PharmD, Ph.D., MD)
10+ years pharmaceutical industry experience, including 7+ years in Regulatory Affairs strategy roles with strong project management skills
Requires innovator clinical drug development experience in the US
Experience in EU, UK or Asia PAC, a plus
Experience working in a complex and matrix environment
Experience directly interfacing with health authorities in the US or EU
Experience in multiple phases of development is required
Experience in oncology is required
Knowledge of the drug development process and global submission process
Knowledge of global regulatory guidelines as they relate to the overall global regulatory strategy
Cross functional partnering skills, team-oriented 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

Ensure the development and flawless execution of regulatory strategies for the assigned projects
Strategic partner for internal cross functional stakeholders both within and external to the regulatory organization
Represents Syndax to regulatory health authorities, e.g. FDA, for assigned projects and/or indications
Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
Work with cross-functional groups to define contributions to submissions
Partner with a regulatory project manager to lead regulatory submission teams for assigned projects
Prepare company team for health agency meetings, as required
Serve as the primary interface with Regulatory CROs for coordination and preparation of investigational application submissions
Responsible for maintaining a working knowledge of the global regulatory environment in relevant disease areas and identify and communicate the implications of identified regulatory trends that may impact the business
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
Prepare, plan and implement new processes and policies to improve efficiency of the Company