- Develop regulatory strategies aligning with business deliverables
- Manage ANDA preparation, review, and submission processes
- Leverage QbR framework and FDA's Product Specific Guidance
- Serve as primary contact with US FDA to achieve company objectives
Regulatory Consultant, ANDA - San Francisco, CA - Pharmatech Associates
Description
Job Summary
Pharmatech Associates Inc. seeks an experienced Regulatory Consultant to lead regulatory strategies for Abbreviated New Drug Applications (ANDA). This remote role requires expertise in FDA regulations and proven track record of successful ANDA approvals.