Staci Ivey Email & Phone Number

I provided leadership and strategic direction for Pfizer/BioNTech’s COVID-19 vaccine, developing competitive regulatory strategies from pre-submission through post-approval to ensure alignment with business objectives and facilitate global vaccine access.Key Achievements:•Global Regulatory Strategy: Led portfolio prioritization, regulatory strategy development, and risk mitigation planning, ensuring regulatory objectives were aligned with business goals to support US and global distribution.•Cross-Functional Collaboration: Partnered with key stakeholders to align regulatory objectives with business goals and communicated market intelligence to senior leaders, optimizing the value proposition.•Regulatory Leadership: Led a team of CMC strategists, coordinating efforts across functional teams to facilitate successful registrations and secure agency approvals.•Agency Engagement: Led discussions with global regulatory agencies, contributing to regulatory approvals and patient access.•Operational Excellence: Implemented process improvements and developed the regulatory framework to transition the program to commercial market readiness.•Product Expertise: Extensive experience with sterile injectable products and various packaging configurations, including multidose vials, single-dose vials, and pre-filled syringes.•Strategic Thinking: Managed complex regulatory questions, applied risk-based approaches, and developed mitigation strategies to ensure compliance and strategic alignment.Throughout my career, I have demonstrated strengths in strategic thinking, influencing, risk evaluation, innovation, initiative, leadership, and communication. My ability to advocate for scientifically sound approaches and lead cross-functional teams has been instrumental in achieving global approvals and driving projects to meet business objectives.

As Global CMC Product Lead for top-volume assets impacting more than 150 markets, I developed comprehensive global regulatory strategies, prepared submission content, and oversaw lifecycle activities across US, EU, and RoW markets.During the transition from Pfizer to Viatris, I seamlessly continued my role, maintaining continuity in regulatory responsibilities for the impacted product portfolios. This transition highlighted my dedication to upholding regulatory strategies and ensuring market supplies as the portfolios moved from Pfizer to Viatris.I provided strategic direction and leadership for high-volume global product portfolios, contributing to successful post-approval submissions for EU, US, and global markets, securing agency approvals for major submissions. Additionally, I managed multiple supply-critical projects, delivering regulatory strategies for global initiatives, including drug product and drug substance site transfer projects.Key Responsibilities:•Cross-Organizational Collaboration: Worked closely with cross-functional teams to define project priorities and ensure alignment with strategic goals.•Regulatory Strategy and Direction: Provided CMC regulatory strategy and direction for global markets, supporting product portfolios through complex regulatory landscapes.•CMC Content Planning and Authoring: Planned and authored post-approval CMC content for global submissions, ensuring compliance with regulatory requirements.•Vendor Support Team Leadership: Offered strategic and operational direction to vendor support teams, optimizing resource allocation and project execution.In this role, my commitment to effective leadership, innovative problem-solving, and global regulatory excellence significantly contributed to the successful integration and management of product portfolios during the business transition.

As Global CMC Product Lead, I developed comprehensive regulatory strategies for top-volume assets and oversaw regulatory compliance activities throughout the product lifecycle across the US, EU, and over 150 markets worldwide. In collaboration with key stakeholders, I effectively developed and implemented multiple strategies to mitigate supply chain disruptions and secure market access.Key Abilities:•Regulatory Strategy Development: Developed robust strategies to support product portfolios from end-to-end, mapping global CMC requirements, negotiating submission content, and preparing submission packages. Successfully managed over 300 technology transfer submissions, resulting in expanded market access.•Cross-functional Leadership: Led cross-functional teams as a regulatory expert, providing guidance and innovative solutions to project complexities. Facilitated a collaborative approach where all-ideas-are-heard; enhancing project efficiency and outcomes.•Project Management: Successfully managed high-profile projects under tight deadlines, ensuring regulatory compliance and alignment with business objectives. Developed robust mitigation strategies, such as one for the US market that protected $41MM in revenue and ensured supply continuity, demonstrating agility and expertise in navigating complex regulatory landscapes. During the divestiture of impacted product portfolios, I provided continuous regulatory support, ensuring a smooth transition to Viatris. My commitment to effective leadership, innovative problem-solving, and global regulatory excellence contributed significantly to the success of these portfolios.

I provided leadership and regulatory strategies for a team of global CMC scientists supporting biopharmaceutical companies. My leadership ensured the delivery of project goals and optimized resource allocation, creating scientifically robust submission packages and right-first-time submissions, resulting in more than 500 product approvals worldwide across +150 countries.Key Achievements:•Strategic Leadership: Developed and implemented comprehensive regulatory strategies for top-volume assets, overseeing regulatory compliance activities throughout the product lifecycle across diverse therapeutic areas, including biologics, small molecules, and combination products.•Global Regulatory Success: Managed global registrations, including the US, EU, and RoW, ensuring compliance with regulatory requirements from pre-submission to post-approval.•Operational Excellence: Enhanced operational efficiencies by implementing best practices and strategic oversight of project operations. Managed high-profile projects under tight deadlines, demonstrating agility with navigating complex regulatory landscapes.•Technical Expertise: Provided regulatory strategies and support for sterile injectable products, including vials, Act-O-Vials, pre-filled syringes, auto-injectors, and sterile ophthalmic solutions.•Team Building: Built strong, diverse teams with complementary skills, fostering open communication and aligning contributions to overall goals.My experience at Cardinal Health highlights my ability to drive business growth, build high-performing teams, and navigate complex global projects. I provided strategic and operational support for partnering companies, collaborating with functional teams, developing submission-ready content, assessing change controls, and responding to agency requests for information. I am dedicated to ensuring high standards in regulatory submissions and strategic operations.