Sr. Director, Regulatory Affairs

Role Summary

Senior Director, Regulatory Affairs to support the continued development of vadadustat in the treatment of anemia, as well as other pipeline products in chronic kidney disease or other therapeutic indication spaces. This individual will operate in a high visibility role and will be responsible for developing and coordinating regulatory strategies and leading IND/CTA and sNDA/NDA preparation and submissions to regulatory agencies. This position reports to the Vice President, Regulatory Affairs.

Responsibilities

• Design and support implementation of well-informed global regulatory strategies
• Represent Regulatory Affairs on project sub-teams (e.g., Product Team, Clinical Team, etc.) and provide regulatory strategy and guidance (e.g. protocol reviews, report reviews, development plans)
• Liaise with and lead the preparation, as well as meetings with Regulatory Health Authorities (e.g. U.S., E.U, Japan)
• Lead the coordination, preparation and timely submission of regulatory documents (e.g. briefing documents, pediatric plans, INDs, NDAs)
• Manage, mentor, and develop direct reports, who may lead their own development programs
• Write regulatory documents (e.g. pediatric plans, briefing documents) to support regulatory agency submissions
• Establish relevant processes and procedures to support the Regulatory Affairs function activities
• Maintain knowledge of US, EU and ROW regulatory requirements and ensure compliance with regulatory requirements
• Articulate complex issues and strategic recommendations concisely and effectively across all stakeholders including senior leaders
• Develop approaches and solutions to achieve business critical goals and/or mitigate risks

Qualifications

• Bachelor's degree in life sciences required; advanced degree preferred
• Minimum of 8 years pharmaceutical industry experience with a minimum of 6 years in Regulatory Affairs
• Evidence of successful submissions to FDA and EMA (e.g. IND, NDA, MAA, briefing packages)
• Experience managing and developing direct reports
• Demonstrated evidence of writing regulatory documents (pediatric plans, Module 1, Module 2, briefing packages)
• Knowledge of US and EU regulatory requirements
• Knowledge of drug development
• Excellent written and oral communication skills
• Excellent interpersonal skills
• Strong project management skills and drive for excellence
• Previous experience working for FDA is a plus

Skills

• Regulatory strategy development
• Regulatory submissions (INDs, NDAs, MAAs, etc.)
• Leadership and people development
• Cross-functional collaboration
• Regulatory affairs knowledge for US, EU, ROW
• Technical writing for regulatory documents

Education

• Bachelor's degree in life sciences required; advanced degree preferred