Reference Number: JO-2106-470033
Director CMC Regulatory Affairs
Job Type: Permanent
Location: San Diego
Director, CMC Regulatory Affairs
San Diego or Remote
This is an exceptional opportunity to join a global biotechnology business at an exciting stage of product development. This is a key role where you will assist in the development and implementation of global regulatory strategy. Youll role will focus on ensuring CMC development and standards for IND and commercial stages, device progress and compliance for approvals, BLA readiness and the preparation and review of documents for submission to global agencies.
Ensures corporate policies and clinical programs are aligned with rules and regulations for global development of pharmaceuticals.
To develop and implement strategies to facilitate timely regulatory application approvals
Oversees assigned projects and resources.
Involvement in product strategy team to give advice, direction and risk identification on global regulatory requirements and strategy.
Work with development teams to write, review and revise documentation for submission to health authorities.
Interact and communicate with health authorities.
Undertake regulatory intelligence activities to remain on top of the global regulatory environment and competitive products and communicate to appropriate teams.
Ensure compliance with the global regulatory health authority regulations and interpretations and develop internal training on regulatory issues for internal teams and stakeholders.
Candidate should ideally be educated to Masters degree or PhD in a relative subject
You will hold at least 5 years experience within a similar CMC regulatory position.
Previous experience gained within a drug development environment.
Proven experience within strategic leadership position
Excellent knowledge of FDA requirements.
Able to demonstrate working knowledge of electronical publishing and file management systems.
You will hold excellent communication skills and the ability to manage and influence others.
First class project & time management skills with the ability to work to strict deadlines.
Experience with Class 3 Devices or combination products would be a major advantage but not essential.
To be considered for this position or to find out further information on the role please e-mail your resume to Gary.Crawley@cpl.com.