Executive Director, Regulatory Affairs

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 (level determined by candidate experience) reporting into the SVP Regulatory Affairs who is responsible for oversight of IND/IMPD, BLA and ex-US activities for the CAR-T and immunotherapy products. The Director/Senior Director, Regulatory Affairs provides regulatory leadership and strategy on cross functional sub teams and advises on best practices providing relevant guidance and regulation including precedence. The Director/Senior Director, Regulatory Affairs will also be responsible for the management and development of the team members reporting to him/her.

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

This position will be onsite in our Germantown, Maryland facility.

DUTIES AND RESPONSIBILITIES:

• Lead cross-functional teams responsible for the preparation of eCTD submissions and responses to Health Authority questions for assigned projects/products.
• Accountable for leading development, review and approval of submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
• Ensure effective communication to SVP Regulatory and disciplinary teams of regulatory strategy, risks, and overall plans.
• Accountable for all regulatory related interactions, resolution of issues and negotiation of approvals with Health Authorities in all regions.
• Partner with multi-disciplinary leads 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 RA 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 five (5) years relevant, progressive experience in the pharmaceutical industry or a regulatory authority capacity, with experience in biologics.
• 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 marketing authorizations, clinical trial applications and post-approval submissions for CAR-T and 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.
• 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.
• 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.

EOE MFDV