Senior Director, Regulatory Affairs

• Identify and implement company regulatory strategies for the global Neurology or Oncology portfolio
• Establish regulatory standards aligned with short- and long-term business plans
• Ensure completion of goals and objectives related to regulatory submissions, milestones, clinical strategies, and trials
• Function as a Regional or Global Regulatory strategy lead
• Oversee regulatory submission activities and review regulatory documents before submission
• Lead strategic regulatory discussions and draft documents for health authorities
• Lead regulatory activities involving strategy and preparation, review, and evaluation of health-authority documents
• Apply scientific, regulatory, and business-process knowledge to execute regulatory strategies
• Identify strategic regulatory opportunities and threats and mitigate risks
• Direct financial planning, forecasting, budget management, vendor management, timeline development and tracking, and resource assessment
• Lead initiatives to improve regulatory strategy processes and systems with key stakeholders
• Define team deliverables, cascade important information, and drive accountability
• Manage people through goal setting, performance management, development, and engagement
• Participate in internal and external committees, health-authority interactions, and organizational decision-making processes

Requirements

• Bachelor's degree and 12+ years of relevant experience
• Experience in Life Sciences industry preferred
• Bachelor's or advanced degree in sciences or related field with significant experience in regulatory/R&D area with drug development and regulatory experience in pharma/biotech industry
• Combination of equivalent education and experience accepted
• Proven experience in strategy development within area
• Operational management of regulatory strategy processes through cross-functional teams
• Budget planning and management experience
• Working knowledge of clinical trial design and processes, including clinical data collection and analysis and preparation of regulatory submissions, preferred
• Track record of interfacing effectively with FDA and some experience with health authorities
• Extensive experience with FDA laws, regulations and guidances, as well as international regulation
• Significant project management experience leading multiple critical complex regulatory strategy projects and programs
• Major submissions (NDA/BLA/MAA/J-NDA) experience, preferred
• Experience managing large regulatory strategy teams directly/indirectly in a leadership capacity, preferred
• Must be available for regular business travel
• Skills: Communication & Cross-functional Influence, Critical Thinking & Business Agility, Mentoring/ People Development, Project Management, Regulatory Strategy Acumen

Core Competencies

Demonstrates extensive experience in Regulatory Strategy Development and Management within the Life Sciences industry, with a strong focus on FDA regulations and drug development processes. Proven ability to lead cross-functional teams, manage budgets, and drive strategic initiatives in regulatory submissions and clinical trials.

Highest-signal resume keywords

• Regulatory Strategy Development
• FDA Regulations and Guidance
• Project Management
• Clinical Trial Design
• Budget Planning and Management

ATS Optimization Keywords

Hard Skills

• Regulatory Submissions
• Drug Development
• Clinical Data Collection
• Regulatory Document Review
• Regulatory Strategy Execution
• Risk Mitigation
• Health Authority Interactions
• NDA/BLA/MAA/J-NDA Experience
• Operational Management
• Cross-Functional Team Leadership

Soft Skills

• Communication
• Critical Thinking
• Business Agility
• Mentoring
• People Development

Industry Keywords

• Life Sciences
• Pharma
• Biotech
• Regulatory Affairs
• Clinical Trials
• Health Authorities
• Regulatory Standards
• Vendor Management
• Financial Planning
• Resource Assessment