Ardea Biosciences, a biotechnology company in San Diego, is searching for a CMC Regulatory/Manager/Sr Associate to join the team. Interested parties can review the job description and apply on-line at: www.ardeabio.com/careers
The CMC Regulatory Manager/Sr 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.
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