Executive Director, Regulatory Affairs

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.
• Able 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.