Director Regulatory Affairs
My client is the largest private employer in the Northeastern US and is a world-renowned leader in education, research, and innovation. In just 2 years they have raised over 60 million dollars in support of gene therapy technology as well as partnered with some of the top biotech companies in the Continental US. They are looking for a Director of Regulatory Affairs to be the right hand of the Executive Director of Regulatory Affairs and establish and direct regulatory strategy for the development of novel programs. In this supportive working environment, you will have the ability to empower yourself in your regulatory career by creating new avenues to treat patients worldwide.
Responsibilities:
- Collaborate with various departments in the organization and conduct of Ph.I trials
- Participate and provide input to discussions regarding full clinical development plans
- Work with the applicable regulatory sponsor to execute this strategy in the United States, Europe and Japan
- Work with applicable stakeholders to establish a regulatory strategy primarily focusing on the lead-in and conduct of Ph.I and Ph.II clinical trials.
- Participate and provide input to discussions regarding full clinical development plans
- Interface, collaborate and provide guidance to an existing Gene Therapy Program project management team and group of scientists who are responsible for non-clinical and manufacturing sections of IND applications
Knowledge and Skills:
- Minimum of 7 years of experience working in a regulatory capacity
- Minimum of a BS in a scientific discipline. MS/PhD/PharmD highly desired
- Experience with biologics (IND) submissions is a must
- Must have working knowledge leading regulatory strategy for IND submissions
- Ability to interact effectively with external business partners and regulatory agencies
- Demonstrated excellence in leadership with ability to motivate and lead people in a complex, changing environment
- Ability to drive results within a cross-functional team/partnership environment in a highly professional way