Contractor, Director, Regulatory Strategy

Duties:

• May lead the Regulatory Subteam for assigned products.
• Ensures aligned strategic messaging and content of global regulatory dossiers.
• May serve as the primary regulatory interface with the Asset Strategy Team and subteams. Proactively anticipates and mitigates regulatory risks.
• Ensures compliance with global regulatory requirements.
• Manages assets through all phases of development from pre-FIH through active life cycle management activities.
• Demonstrates an understanding of drug development and exhibits leadership behaviors consistent with level.
• Has direct experience with regulatory acceleration strategies, developing regulatory strategy, analyzing regulatory precedence and operational excellence in execution of regulatory strategy.
• 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 client to regulatory health authorities, e.g. FDA, for assigned projects.
• 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.

Qualifications:

• Bachelor’s degree in scientific discipline; advanced scientific degree preferred (PharmD, Ph.D., MD).
• Regulatory Affairs Certification highly desirable.
• 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 rare disease, immunology or oncology is highly desirable.
• 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.
• Experience working within corporate partnerships is a plus.
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.