Syndax Pharmaceuticals is looking for an Associate Director, Regulatory Strategy to develop and implement regulatory strategies for assigned products in the assigned therapeutic area. The role will lead a team of regulatory professionals and ensure compliance with global regulatory requirements.
Requirements
- Bachelor's degree in scientific discipline; advanced scientific degree preferred (PharmD, Ph.D, MD)
- Regulatory Affairs Certification is highly desirable
- 8+ years pharmaceutical industry experience, including 5+ years in Regulatory Affairs leadership roles
- Global experience desired
- Requires innovator drug development experience in the US and EU/UK/EEA
- Experience in Asia PAC, a plus
- Proven 5+ years in a strategic leadership role with strong project management skills
- Experience working in a complex and matrix environment
- Experience directly interfacing with health authorities in a major market
- Experience in multiple phases of development is required
- Experience in rare disease, immunology or oncology is highly desirable
- Knowledge of the drug development process and global submission process
- Knowledge of global regulatory guidance 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
- Experience working within corporate partnerships is a plus
Benefits
- Total compensation and rewards package that is among the most competitive in the industry
- Base pay within a range of $200,000 - $225,000
- Equity offering
- Annual target bonuses
- Outstanding benefits program
