Layer, Chiang, et al. Genome Biology
The CMC Regulatory Manager/Associate assists in planning, reviewing, and preparing CMC (chemistry, manufacturing and control) submissions to support clinical trials and product approvals. Provides advice on CMC strategies and provide solutions consistent with global guidelines and regulations. Participate on development teams
Primary Duties and Responsibilities
•Coordinate the compilation and writing of CMC sessions 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 International Regulations and appropriate guidance and support of regulatory impact assessments for change control for compounds.
•Assist with 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.
•Interacts 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.
•Must have a 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 is required.
•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 have the ability to adhere to timelines.
•Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project and 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%
Interested parties please apply on-line at: www.ardeabio.com/careers