Senior Director, Regulatory Affairs
We are seeking a highly motivated Senior Director to lead our regulatory affairs team in developing and implementing global CMC regulatory strategies for all development-stage programs and marketed products. The successful candidate will provide strategic and operational regulatory direction, mentorship, and leadership on projects including CMC regulatory strategies, requirements for development programs and commercial products in domestic and global markets.
Responsibilities:
* Provide strategic and operational regulatory direction and mentorship on projects.
* Develop and implement global CMC regulatory strategies for all development-stage programs and marketed products.
* Review and analyze complex CMC regulatory issues and support global development and commercialization of programs.
* Liaise with global regulatory authorities as needed for all aspects related to drug development.
* Maintain awareness of the global regulatory environment and assess the impact of changes on business, development programs, and commercial products.
Requirements:
* BA/BS in a scientific field of study with 15 years + of relevant experience working in Regulatory in the pharmaceutical/biotech industry.
* Extensive experience in CMC Regulatory including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory/CMC teams.
* Strong business acumen and ability to make sound decisions that contribute positively to the business.
This is an exciting opportunity to work with a talented team and contribute to the success of our organization. If you have a passion for regulatory affairs and a strong background in CMC, we encourage you to apply for this role.