Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.

We are seeking a global Executive Director, Regulatory Affairs, Gene Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.). This person will provide regulatory leadership and strategy on cross functional sub teams and advise on best practices providing relevant guidance and regulation including precedence. The Executive Director, Regulatory Affairs will also be responsible for the management and development of the team members reporting into him/her.

This role is responsible for defining regulatory strategy, planning and the preparation of US and global regulatory submissions to achieve timely approvals of initial biologic licensing and marketing authorization applications and post-approval lifecycle changes for Precigen’s AdenoVerse™ immunotherapy Products.

This position will be onsite in Germantown, Maryland.

DUTIES AND RESPONSIBILITIES:

• Provides high level strategic regulatory input to the business, ensuring clinical, nonclinical, and CMC activities are compliant with US and international regulations and consistent with the Global Regulatory Strategies for assigned projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.
• Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
• Develop and implement strategies for the timely preparation and execution of regulatory documents to regulatory authorities
• Provides strategic guidance and analysis of regulatory guidance documents, regulations or directives that influence Precigen’s operations and impacted programs.
• Preparation of briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs/BLAs, and Annual reports
• Lead cross functional teams in major regulatory submissions (BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
• Develop the health authority engagement strategy and interaction plan, drive the formulation of regulatory documents focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
• Responsible for the negotiations with health authorities and initiate and deliver key regulatory documents.
• Accountable for all regulatory related interactions, resolution of issues and negotiation of approvals with Health Authorities in all regions.
• Partner with cross functional teams for exchange of project/product related information and submission planning.
• Monitor and influence changes in the global Regulatory environment in alignment with business needs.
• Defines and communicates the need for internal and/or external regulatory resource to the SVP Clinical Operations as required to deliver submissions for assigned projects/products in all regions to the agreed timelines.
• Develop soft and technical skills, ensuring coaching and mentoring of the assigned team.

EDUCATION AND EXPERIENCE:

• Master’s or PhD degree in Life Sciences, Biotechnology, or relevant Pharmaceutical Science.
• Minimum of fifteen (15) years of pharmaceutical experience with ten (10) years of regulatory affairs experience including two to three (2-3) years in Commercial Regulatory experience working with biologics, preferably Gene therapy products.
• Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.
• Successful leadership in delivering Regulatory Submissions for marketing authorizations, clinical trial applications (IND/CTA/IMPD) and post-approval submissions for gene therapy products
• Demonstrated inclusive leadership, emotional intelligence and strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
• Significant experience in all aspects of meeting with Regulatory/Health Authorities supporting drug development
• Ability to apply knowledge of FDA, EMA Global Health Authority requirements and ICH guidelines both strategically and operationally and provide direction to resolve complex regulatory issues.
• Expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA/BLA, Scientific Advice), NDAs/BLAs, and other major regulatory submission.
• Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
• Demonstrated ability to pioneer and execute on an agreed global regulatory strategy and ensure that results are in alignment with business priorities.
• Recognized experience in people development and management.

DESIRED KEY COMPETENCIES:

• Strong analytical and decision-making skills with attention to detail and quality.
• While not required, experience in Oncology drug development is important
• Strong organization and time management skills, an ability to work on multiple projects simultaneously, and excellent attention to detail.
• Ability to anticipate and solve problems while analyzing complex issues and environments.
• Ability to communicate and work effectively with all levels of employees in various communication mediums.
• Ability to understand and execute on the company’s mission and values.
• Strong personal leadership and self-direction.
• Clear communication in both oral and written form.
• Demonstrated ability to work and coordinate with multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.

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