Position Overview:

This Director position, reporting to Senior Vice President, Head of Regulatory Affairs, will be a member of the regulatory CMC team within the Regulatory Affairs organization, responsible for the development of CMC regulatory strategies and lead/support the interactions with the global regulatory authorities on CMC regulatory topics and the preparation of the CMC sections for agency meetings and regulatory submissions, including, but not limited to, briefing documents, IND/IMPD and BLA/MAA. In addition, s/he will also serve as the global CMC regulatory lead for the assigned program(s) with the overall CMC regulatory responsibilities for a specific programs. Internally, this role will work as a member of the regulatory subteam to develop innovative CMC regulatory approach, best regulatory practice, interact cross-functionally with product development CMC team members to provide regulatory guidance, serve as the CMC 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 CMC development. This role will require both the capacity to work independently, as well as manage external vendors.

Key Responsibilities:

• Serve as the CMC Regulatory Lead for assigned product(s), provide CMC regulatory leadership and guidance to the product development team for a well thought through overall CMC regulatory strategy leading to successful regulatory meetings, submissions and approvals
• Serve as CMC regulatory representative for assigned product(s) for global CMC regulatory responsibilities, including, but not limited to, the development and implementation of CMC regulatory strategy in US, EU and the rest of world
• As a member of 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
• As the primary CMC regulatory lead person of assigned project(s) responsible for all CMC regulatory matters, lead/support regulatory interactions with the global healthy authorities
• 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/support the preparation and interactions with regulatory authorities
• Lead the preparation of regulatory submissions such as INDs to FDA and other health authorities 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
• Working 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 CMC regulatory role
• Demonstrated track records of successful regulatory meetings, IND/IMPD/CTA or BLA/MAA submissions and approvals
• Hands-on CMC regulatory writing, extensive understanding of requirements for regulatory submissions, including IND or BLA and overall preparation of regulatory submissions for cell and gene therapy products
• Extensive knowledge of CMC product development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies
• Prior subject matter expertise and work experience in a CMC technical role in order of relevance in gene editing, gene therapy and biologics product development strongly desired
• 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 with cross-functional teams and 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.