Cynthia Barber

Defined the technology innovation strategy that aligned with the company's business objectives which involved understanding market trends, technologies and customer needs to identify opportunities for innovation.

Scouting and evaluation of new technologies, startups and competitors that could impact the business.

Formed startegic partnerships with other companies and academic institutions

Advocated for new technologies within the organization, helping to overcome resistance to change and acting as a spokesperson for the company's technological vision externally.

Ensured compliance with regulatory standards and internal governance, while also considering the ethical implications of new technologies.

Developed and implemented a regulatory strategy that aligns with the company's business goals, ensuring that new and existing products meet the standards set by regulatory agencies around the world.

Ensured that all products, labeling, and promotional materials are in compliance with local, regional, and international regulations and standards related to infant formula and baby foods. This often involves familiarity with standards set by the FDA, WHO, and EU, as well as other relevant regulatory bodies.

Managed the process of obtaining approvals for new products and maintaining registrations for existing products, which can be complex given the variability in regulations between different countries.

Oversaw the preparation and submission of regulatory filings, including product registrations, license renewals, and responses to regulatory agencies’ questions. Average 26 US infant formula submissions per year with 100% clearance to market rate.

Kept up to date with changes in regulatory legislation and guidelines that affect infant formula, and assess the potential impact on the company’s product portfolio. This function includes tracking policy developments related to nutritional content, labeling laws, and safety concerns.

Collaborated with various departments such as Research and Development (R&D), Quality Assurance, Legal, Marketing, and Production to ensure regulatory requirements are met throughout the product lifecycle from conception, development, manufacture, and market launch.

Identified and assess regulatory risks associated with the company’s product portfolio and develop strategies to mitigate these risks.

Prepared for and manage audits and inspections by external regulatory authorities, ensuring that all necessary documentation is available and processes are in-line with compliance requirements.

Acted as the primary contact point for regulatory authorities and industry associations. The VP might also negotiate with regulatory authorities for product approvals and represent the company at regulatory meetings or industry forums.

Developed internal policies and procedures related to regulatory compliance, product safety, and reporting.

Ensured that staff within the regulatory affairs department and other relevant departments are continually trained on regulatory issues and changes that may affect the company.

Handled regulatory crises, such as product recalls or adverse findings by regulatory agencies, which might involve close coordination with public relations and legal teams.

Established the regulatory affairs function from scratch, including creating standard operating procedures, regulatory strategies, and compliance processes tailored to the startup's needs

Collaborated closely with the R&D team to guide the development of safe and compliant infant formula products from an early stage, ensuring that formulation and labeling meet regulatory standards

Handled multiple roles such as regulatory submissions, compliance monitoring, quality assurance, and even elements of legal advice.

Prepared and submitted all necessary documentation for product approvals and ensuring that all regulatory milestones are met with an eye on speed-to-market.

Stayed current with the evolving regulatory environment concerning infant formula to anticipate changes that might affect the business and adapting strategies accordingly.

Directly engaged with regulatory bodies and health authorities to negotiate product approvals, respond to inquiries, and ensure the company is positioned favorably in terms of regulatory compliance.

Raised awareness about regulatory requirements within the company and educating other teams about the impact of these regulations on their work, such as marketing, sales, and operations.

Budget management

Risk management

Built a regulatory and quality team

Held multiple position at the University of Virginia in pharmaceutical and biochemical research.

Designed and performed experiments to investigate G-protein coupled receptor binding to identify new drug targets; histone modification on gene expression and centromere-specific changes during mitosis that lead to abnormal chromosome division.

Supervised and mentored junior researchers, research assistants or students, including overseeing their work and providing guidance.

Wrote grant applications, research papers, reports and presentations to communicate findings to the scientific community.

Ensured compliance with ethical regulations in conducting research.