Paula Opal

Background

About Paula Opal

Highly skilled regulatory professional with over 20 years of experience in the pharmaceutical industry providing strong leadership, critical thinking, and strategic capabilities complimented with extensive experience in clinical development of small and large molecules for high unmet need diseases. Successful track record of developing and managing regulatory strategies across a range of therapeutic areas and products, leading interactions with health authorities, and overseeing effective regulatory teams. Hands-on experience developing key regulatory submissions (e.g. INDs, NDAs, BLAs, global CTAs, etc.) and working collaboratively with cross-functional team members, development partners, and external consultants. Proven ability to build and lead high performance teams and deliver results in matrixed organizations covering diverse therapeutic disease areas. Regulatory Expertise: Managed regulatory strategy for products from Pre-IND through eCTD, including original submissions, supporting amendments, briefing documents, labeling, and annual reports. Detailed knowledge of regulatory requirements at each stage of drug development, including ICH standards for international clinical trials. Experienced in interpreting federal regulations, understanding government agency processes, and managing inspections with related compliance issues. Expertise in reviewing complex scientific documents and technical reports ensuring accuracy of data, clarity of language, and consistency of style. Organizational Talent: Accomplished at understanding project deliverables, defining project scope, establishing schedules, and fostering team relationships. Developed and maintained standard operating procedures, department workflows, and compliance programs within a regulated environment. Expertise in managing content of large submissions, overseeing publishing process, establishing priorities, and coordinating legacy documents.