Vice President, Head of Global Regulatory Affairs
Editas Medicine, United States

Key Responsibilities amp; Accountabilities:

• Develop US and global regulatory strategies aligned with business objectives, including novel strategies for drug development and approvals
• Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
• Provide a strategic view to the structure and design of the regulatory organization. Recruit and manage a team of professionals, as needed
• Responsible for regulatory strategy, submissions, global health authority interactions for the Company’s portfolio from the initiation of development through commercialization
• Oversee the management of all aspects of label development
• Participate in leadership/governance committees, cross-functional and regulatory initiatives to shape and drive regulatory contributions/voice
• Ensure compliance of operations with global regulatory authority requirements and industry standards
• Relationship management and constructive partnering with US and international Health Authorities
• Represent the regulatory function on cross-functional development teams
• May participate in due diligence evaluation of licensing opportunities and provide contract review.

Requirements

Knowledge, Skills amp; Capabilities:

• Experienced strategist with a track record of developing innovative regulatory strategies supporting significant submissions, including original NDAs/BLAs.
• Extensive experience in relevant aspects of drug regulatory affairs and drug development, including biologics and rare diseases and preferably experience with gene therapy and cellular therapy products
• Effective cross functional team leader, with willingness to mentor, coach, and support less experienced colleagues
• Ability to function independently as a decision-maker on regulatory issues and to to integrate business needs and regulatory requirements. Understanding of scientific principles and global regulatory requirements for development as well as post-market

• Able to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.

Education amp; Relevant Work Experience:

• Advanced degree in relevant scientific field
• A minimum of fifteen years professional experience in the biotechnology/pharmaceutical environment in the development of biological and pharmaceutical products
• At least 5 years of experience leading a high-performing team of regulatory affairs professionals
• Senior-level experience interacting with US and international regulatory authorities (eg. FDA, EMA, and PMDA)

Physical amp; Travel Requirements:

• Willingness to travel for meeting with global regulatory authories as required, including overnight trips. Some international travel may be required.

Job Rewards and Benefits