Director, Regulatory Strategy, Planning & Operations

• Oversee strategic activities including objective and goal setting, quarterly reporting, resource and budget planning oversight, team communications, alignment of interdepartmental and cross-functional activities, and issue management
• Collaborate with RA, GPS & DQ functional lines and facilitate execution of strategic objectives
• Spearhead initiative implementation, project tracking, and cross-functional stakeholder connections
• Support stakeholder management across RA, GPS & DQ
• Monitor operational performance and quality delivery across the functional organization
• Drive development and tracking of functional goals, periodic functional reviews, quarterly status updates, and issue escalation and resolution
• Develop, maintain, and review management reports and dashboards
• Facilitate planning discussions and provide insights for leadership decision-making
• Support job description development, requisition management, headcount openings, and active postings
• Collaborate with HR on employee onboarding, engagement, and talent review processes
• Support budget planning and spend tracking with functional leadership and Finance
• Own functional meetings, communications, engagement activities, and team events
• Prepare agendas and meeting materials, track actions and deliverables, and drive follow-up activities
• Ensure communication cascades within and outside the organization
• Represent the functional Senior Leadership Team at delegated meetings, events, and activities
• May directly supervise administrative support staff for select activities and projects
• Participate in operational optimization and continuous improvement initiatives
• Foster a team environment reflecting the Regeneron Way

Requirements

• 10+ years of pharmaceutical or biotechnology industry experience, including planning and operations experience within a global development organization
• Demonstrated experience providing strategic oversight, coordination, and operational leadership across cross-functional teams
• Minimum BA/BS in Business, Marketing, Finance, Science/Technology, or a related field
• Knowledge of pharmaceutical/biotechnology operations and an understanding of drug development
• Expertise in Microsoft applications including Teams, Project, PowerPoint, Word, and Excel
• Highly organized and detail-oriented, with the ability to synthesize information and think strategically
• Self-motivated, flexible, proactive, and able to operate effectively in an ambiguous, fast-paced environment while meeting deadlines under pressure
• Demonstrated ability to prioritize and manage multiple projects simultaneously
• Proven ability to work effectively with individuals at all levels of the organization, including senior leadership
• Experience contributing to or leading cross-functional strategic change initiatives
• Excellent interpersonal, teamwork, and stakeholder management skills
• Strong written and verbal communication skills, including the ability to summarize complex information clearly and concisely
• Effective influencing and negotiation skills
• Ability to handle confidential information with discretion

Core Competencies

Demonstrates extensive experience in strategic oversight and operational leadership within the pharmaceutical or biotechnology industry, with a strong focus on cross-functional collaboration, project management, and stakeholder engagement. Proficient in utilizing Microsoft applications to support planning, reporting, and communication efforts.

Highest-signal resume keywords

• 10+ Years Pharmaceutical Industry Experience
• Strategic Oversight and Coordination
• Cross-Functional Team Leadership
• Microsoft Applications Expertise
• Stakeholder Management Skills

Hard Skills

• Project Management
• Operational Leadership
• Budget Planning
• Resource Planning
• Data Analysis
• Performance Monitoring
• Issue Management
• Management Reporting
• Continuous Improvement
• Drug Development Knowledge

Soft Skills

• Highly Organized
• Detail-Oriented
• Self-Motivated
• Effective Communication
• Interpersonal Skills

Industry Keywords

• Pharmaceutical Operations
• Biotechnology Operations
• Global Development Organization
• Cross-Functional Collaboration
• Stakeholder Engagement

Tools & Technologies

• Microsoft Teams
• Microsoft Project
• Microsoft PowerPoint
• Microsoft Word
• Microsoft Excel