Senior CMC Regulatory Associate

Organization: 
Ardea Biosciences/AstraZeneca
Job Location: 
San Diego, CA
Job Description: 

We are seeking a Senior CMC Regulatory Associate who will assist in planning, reviewing, and preparing CMC (Chemistry, Manufacturing and Controls) submissions to support clinical trials and product approvals. Provides advice on CMC strategies and provides solutions consistent with global guidelines and regulations. Participate on development teams.
For more Information on Job Responsibilities and Requirements - Interested parties please apply today at: www.ardeabio.com/careers

Responsibilities include:
• Manage and coordinate the content development process (creation, review and assembly) of regulatory CMC documentation for inclusion in submissions to health authorities.
• Prepare CMC data for inclusion in regulatory submissions supporting development activities, including NDAs, INDs, IMPDs, QOSs (Canada), CTAs and DSURs/annual reports.
• Interact with internal and external stakeholders as necessary to support efficient and effective product development together with generation and management of associated regulatory CMC documentation.
• Assist in development of effective regulatory CMC strategies for product development, and effectively communicate to development team.
• Review documents related to clinical trial material supplies.
• Review product-related change control documents and assess regulatory impact of proposed changes.
• Ensure compliance with applicable industry standards, FDA and international regulations, and appropriate guidance.

Requirements: 

• BA/BS in a science-related discipline (e.g. chemistry, biochemistry, biology) with five 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 - GMP guidelines, 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
Apply online at: www.ardeabio.com/careers

Contact Information: 

For more Information on Job Responsibilities and Requirements - Interested parties please apply today at: www.ardeabio.com/careers

About Our Organization: 

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 is seeking a Senior CMC Regulatory Associate to join its dynamic team.