Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
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.
·PhD, MA/MS, or BA/BS in chemistry or related field, with 7 plus years’ industry experience and at least two years regulatory experience.
·Working knowledge of the drug development process in general, and CMC regulatory requirements in particular.
·Strong working knowledge of ICH – GCP guidelines, and EMA and FDA regulations/guidelines related to the conduct of clinical trials.
·Prior experience working in manufacturing, pharmaceutical science or other product development function.
·Demonstrated ability to coordinate and work effectively with cross-functional teams.
·Superb attention to detail.
·Ability to multi-task in a time pressured environment.
·Excellent written and verbal communication skills.
·Ability to problem-solve independently.
·Good organizational skills and ability to adhere to timelines.
·Excellent computer skills with the following programs: MS Word, PowerPoint, Excel and MS Project; ability to use ISI writer or comparable templates.
·Proficiency in strategizing, planning, monitoring and problem-solving.
·Some travel is to be expected up to 30%.
Apply online at: www.ardeabio.com/careers