Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.
Ardea Biosciences is searching for a Regulatory CMC Manager/Associate Director to join the team.
The Regulatory CMC Manager/Associate Director leads the regulatory strategy for, and execution of, global CMC (chemistry, manufacturing and controls) activities leading to submission and approval of product marketing applications for Ardea assets. The incumbent will assist in planning, reviewing, and preparing regulatory CMC documentation in CTD format to support clinical development and commercial product approvals. They will provide advice and counsel consistent with global guidelines and regulations to colleagues in pharmaceutical sciences, quality, and manufacturing via participation on development teams.
Primary Duties and Responsibilities
- Coordinate the compilation and writing of CMC sections for Ardea’s products for US, EU and Canada in compliance with applicable ICH, FDA and EMA guidelines.
- Summarize CMC data for regulatory submissions including INDs, CTAs and annual reports.
- Ensure compliance with applicable industry standards, FDA and global health authority regulations, and appropriate guidance.
- Develop and support regulatory risk assessments related to change control.
- Lead the development of effective CMC regulatory strategies for product development and regulatory submissions, and effectively communicate to development team.
- Interact with regulatory authorities (FDA, EMEA, Health Canada, etc.), as directed.
- Interact with internal and external partners as necessary to support efficient and effective product development and project coordination.
- Performs other related duties as assigned.
- Able to work independently on assigned tasks.
BioSpace.com - 24 months ago