Senior Director, Regulatory Affairs

Description

Global Life Science Hub is thrilled to announce its partnership with an Artificial Intelligence biotech committed to pioneering cancer treatment through groundbreaking gene therapy methodologies. By harnessing predictive analytics, machine learning, and AI technologies, they pinpoint highly expressed genes and pioneer novel CAR-T Cell Therapies. Their innovative strategy utilizes the body’s immune system to precisely target cancer cells with unprecedented precision.

Following the remarkable success of their phase I study enrolment, their stock performance reflects their ongoing achievements, soaring by an unprecedented 300% this year alone. This exceptional growth has led to the appointment of a new Director of Regulatory Affairs, who will play a pivotal role in orchestrating the filing of a new IND.

Responsibilities:

• Define the future vision and implement strategies in close alignment with internal innovation initiatives
• Lead all aspects of submission publishing and archiving activities globally associated with generating highly complex electronic submissions within Global Regulatory Operations
• Provide cross-functional leadership for complex global filings and work collaboratively with external functions
• Provide decision support to the wider business in relation to new and proposed regulations/changes and how they impact on regulatory road maps and strategy planning
• Identify opportunities to further advance outsourcing strategies to leverage efficiencies in operations and provide more bandwidth to address the growing business needs for marketed products and development programs across the regions
• Develop deep strategic relationships with vendors and lead governance meetings
• Responsible for planning of resources, forecasting and budgeting
• Ensure the company follows all regulatory technical guidance requirements for all submissions globally

Experience/Qualifications:

• A bachelor in a life science sector at a minimum
• 10 years Regulatory Affairs experience
• Strong IND and NDA submissions
• Extensive FDA experience
• Experience in Cell Therapy is highly desirable

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com