Sandra R. Kircus

Lead the regulatory strategy for localized drug delivery product lines (drug led and device led combination products) within a global business unit, overseeing regulatory execution across development and commercial programs. Advise on strategic, scientific, and regulatory matters, proactively identify program risks and formulate mitigation strategies. Manage a team of X-XX with full accountability for a $XM cost center. Report to the VP of Quality and Regulatory Affairs and work closely with executive leadership, R&D, clinical, quality, and commercial teams to align the regulatory roadmap with overall enterprise objectives.

Provided direction for the global CMC regulatory strategy across multiple concurrent client programs, overseeing a team of 10. Managed complex regulatory submissions and agency interactions across FDA, EMA, Health Canada, and other global authorities. Owned end-to-end program delivery and client relationships while serving as a senior advisor on high-risk regulatory challenges. Developed and administered a multi-million dollar annual departmental budget. ✔ Drove successful regulatory outcomes for multiple clients following FDA Complete Response Letters by redesigning the regulatory strategy and execution, resulting in approvals across three programs. ✔ Built and scaled the small molecule regulatory business from a single client to five active clients, generating $2M in incremental revenue and expanding the firm’s market position. ✔ Served as strategic regulatory advisor to leading organizations, influencing critical development and submission strategies. ✔ Led global submissions including INDs, NDAs, BLAs, ANDAs, DMFs, and CTAs, ensuring alignment with evolving regulatory requirements and agency expectations. ✔ Reengineered regulatory content and facility strategies in response to adverse FDA feedback, converting negative regulatory positions into successful outcomes. ✔ Enhanced team capability and delivery performance through mentoring, improving quality and consistency across client engagements.

Directed the US regulatory CMC strategy and served as the service area leader, overseeing multiple client programs and mentoring a team of regulatory professionals. Worked with senior client stakeholders to guide regulatory strategy across development and submission activities. Managed program deliverables and budgets for all client-facing programs. ✔ Delivered strategic regulatory guidance across multiple high-value programs including risk mitigation strategies, improving submission quality and increasing likelihood of approval. ✔ Significantly improved the client engagement model, enhancing delivery consistency and expanding opportunities for follow-on business. ✔ Led program discussions and provided strategic, scientific, and regulatory input with various project scopes including PIND, IND, NDA, ANDA, BLA, and DMF submissions and lifecycle management. ✔ Developed and managed program budgets and delivery timelines, ensuring alignment with client requirements and organizational goals.

Served as the global CMC regulatory lead for development and commercial products within a virtual manufacturing model, working collaboratively with internal and external stakeholders to drive regulatory strategy and execution. Provided expert regulatory guidance to project teams from early development through post-approval. ✔ Resolved Agency deficiencies, successfully addressing all regulatory concerns and enabling product approval. ✔ Led the global regulatory strategy across development and post-approval lifecycle, ensuring alignment with program milestones and commercial objectives. ✔ Provided proactive guidance on manufacturing changes and regulatory risk, minimizing impact to development timelines.

Progressed through multiple roles of increasing responsibility, ultimately leading regulatory strategy for global biologics product lines across development and commercial stages. Served as the Global CMC lead for assigned development and commercial product lines, defining the global submission strategy and coordination. Managed direct reports and partnered with global teams across R&D, manufacturing, and quality. ✔ Played a key role in resolving a site under consent decree, resulting in successful remediation and full restoration of regulatory compliance. ✔ Led the regulatory strategy to consolidate multiple filings into a unified global submission, enabling product rebranding and streamlined lifecycle management. ✔ Directed global submissions and agency interactions, ensuring consistent regulatory positioning across regions. ✔ Mentored junior staff to ensure appropriate growth and professional development. ✔ Significantly enhanced overall regulatory risk management across product portfolios, improving compliance and reducing delays.

Proactively recruited to lead the US regulatory strategy for a growing organization entering the U.S. market, operating in a fast-paced, resource-constrained startup environment. Served as the primary point of contact for all relevant government agencies. ✔ Developed innovative regulatory pathways that accelerated market entry and revenue generation. ✔ Served as the primary liaison to FDA and regulatory agencies, establishing the company’s regulatory presence in the U.S. ✔ Provided technical and regulatory expertise for due diligence on potential new products.

Led regulatory and quality activities for multiple client programs within a startup environment, managing a team of five and supporting diverse therapeutic areas. Served as Interim Manager QA Manager’s absence. ✔ Directed regulatory strategy and submissions across multiple programs, ensuring successful product development and compliance. ✔ Enhanced quality and regulatory integration, improving alignment with GMP and FDA requirements. ✔ Conducted technical and regulatory review of GMP documents, including batch records, raw material and finished product release specs. Reviewed all submissions and product labeling for technical and regulatory composition. ✔ Served as the primary contact to all relevant government agencies, including the U.S. FDA and the DEA.

Hired to work on a contract basis to align SOPs with cGMP regulations. ✔ Ensured Standard Operating Procedures were parallel with current lab practices. ✔ Maintained consistency between documents and ensured scientific integrity and cGMPs.

Led laboratory initiatives supporting regulatory compliance of imported food and drug products with FDA regulations. ✔ Contributed to Quality Assurance initiatives in moving toward ISO accreditation. ✔ Served as Interim Supervisor, guiding team operations and technical execution. Performed peer reviews on analyses. ✔ Validated protocols not previously used in the FDA laboratory.