Position Overview:

This Director position, reporting to Senior Vice President, Head of Regulatory Affairs, will be a member of the regulatory strategy team within the Regulatory Affairs organization, responsible for the development of non-clinical and clinical regulatory strategies and lead the interactions with the regulatory authority, FDA, in US and the preparation of agency meetings and regulatory submissions, including, but not limited to, briefing documents, IND and BLA. In addition, s/he will also serve as the global regulatory lead for the assigned program(s) with the overall regulatory responsibilities for a specific programs. Internally, this role will work with the regulatory team to develop innovative regulatory approach, best regulatory practice, lead the regulatory subteam, interact cross-functionally with product development team members to provide regulatory guidance, serve as the regulatory lead on cross-functional program team, and align with all stakeholders including senior management. This role is both strategic and operational, will operate in a matrixed environment including extensive collaboration with research, non-clinical and clinical development. This role will require both the capacity to work independently, as well as to manage external vendors.

Key Responsibilities:

• Serve as the Global Regulatory Lead for assigned product(s), provide regulatory leadership and guidance to the product development team for a well thought through overall regulatory strategy leading to successful regulatory meetings, submissions and approvals
• Serve as regulatory representative for assigned product(s) for all regulatory responsibilities, including, but not limited to, the development and implementation of non-clinical and clinical regulatory strategy in US
• Lead the Global Regulatory subteam consisting of all regulatory disciplines to plan, coordinate, execute and communicate regulatory deliverables to the project team, broader organization and senior management
• Serve as the primary regulatory lead person of assigned project(s) for interactions with the US regulatory authority, FDA for all regulatory matters
• Work with internal stakeholders and regulatory agencies for regulatory approaches to innovative products based on the prime editing technology
• Maintain knowledge of relevant regulations and guidances. Assess and communicate regulatory requirements and expectations to ensure all product development activities are in good compliance with applicable regulations and guidances
• Prepare, write, review regulatory meeting requests and briefing documents and lead the preparation and interactions with regulatory authorities
• Lead the preparation of regulatory submissions such as INDs to FDA for gene editing products and companion diagnostic tests
• Manage on-going regulatory submissions and reporting requirements, including annual and periodic reports
• Lead and manage the regulatory aspects of product and project deliverables, timelines and budget
• Work with the Head of Regulatory Affairs, lead, participate and contribute to initiatives and activities to help build a robust high performing regulatory affairs organization including operational excellence for effective and efficient execution
• Identify, engage and collaborate with external regulatory experts and consultants

Qualifications:

• Bachelor’s degree in Life Sciences or related fields required; advanced degrees such as PhD in biomedical sciences or related fields preferred. A degree in regulatory disciplines or Regulatory Affairs Certification (RAC) certification is a plus but not required
• Minimum 10 years of post-undergraduate experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role required
• Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies
• Demonstrated track records of successful regulatory meetings, IND or BLA submissions and approvals
• Prior regulatory and technical experience in order of relevance in gene editing, gene therapy and biologics product development strongly desired
• Extensive understanding of requirements for regulatory submissions, including IND or BLA. Hands-on regulatory writing and overall preparation of regulatory submissions for cell and gene therapy products
• Excellent written and oral communication skills
• Demonstrated ability to blend analytical critical thinking, problem-solving, organizational and negotiation / decision-making skills to enable scientific data-driven, regulatory compliant narratives of regulatory documents
• Experience in working on cross-functional teams, providing regulatory subject matter guidance
• Demonstrated ability to work in an innovative and fast-paced environment
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.