Experienced interacting, in person and in writing with FDA, EMA and other global health authorities, with working knowledge of regulatory aspects of operations, regulatory project management, medical writing and advertising, labeling and promotion working closely with commercial and clinical development teams to support program objectives.• Leads the Blueprint GRS Operations team, inclusive of regulatory operations, regulatory project management, advertising and promotional compliance, information systems, intelligence & policy, and medical writing. • Accountable for the operational support for all regulatory submissions including NDA, MAA and NDS, etc. (all application and submission types, i.e. Original, Supplement, Amendment, Clinical, CMC, Nonclinical, etc.) per Blueprint global business priorities.• Accountable for the medical writing support for all internal clinical protocol amendments and regulatory writing vendors.• Accountable for providing strategic guidance on the development and implementation of a creative and compliant advertising and promotion program for commercial oncology and rare-disease portfolio.• Develops solutions to complex business issues by utilizing scientific and regulatory knowledge to support commercial and clinical objectives and initiatives while effectively managing business risks.• Accountable for maintaining regulatory information systems and ensuring access to regulatory intelligence and policy matters pertain to our business. • Accountable for regulatory program management for all programs and major regulatory submissions.

Sr. Director, Regulatory Affairs, Advertising & Promotion responsible for providing strategic guidance on the development and implementation of a creative and compliant advertising and promotion program for a pre-launch and commercial oncology and rare-disease portfolio. Provide strategic advice on advertising & promotion materials, in accordance with the requirements of the US Food and Drug Administration (FDA), company policy, and business goals and objectives. Also ensuring effective communication and constructive working relationships with regulatory authorities and internal/external collaborators.

Oversee the development and execution of all monitoring and auditing activities, including conducting the annual risk assessment. Also responsible for the investigations process, database/hotline, and timelines, as well as the third party due diligence process.Key Accountabilities / Responsibilities• Conduct annual risk assessment to develop the auditing and monitoring plans, making adaptions consistent with dynamic business risks as needed • Conduct monitoring; identifying potential areas of vulnerability and risk, and providing guidance on handling and avoiding such situations• Develop and implement corrective action plans in partnership with functional leadership for resolution of problem areas or gaps• Manage live and online auditing and monitoring, including metrics and meaningful reporting for committee meetings. Strategically select auditing and monitoring samples and identify trends and potential risks• Recognize and respond to compliance issues in a timely manner; following up to resolve and improve processes• Own and continually improve due diligence process, including related government documents and relevant system and cross-functional alignment• Manage all investigations and related processes, collaborating with relevant members of management, legal, HR, and other departments to ensure appropriate outcomes, and serving as a touchpoint for investigations committee members

Accountable for supporting and partnering the MAPS and Govt Affairs teams to achieve their strategic objectives with integrity and high ethical standards, consistent with Company Code of Conduct, Global and US Policies, relevant laws, regulations and values. Champion the ongoing improvement of a robust Compliance program across the business, including delivering effective training, proactively partnering the business and Compliance colleagues to identify and manage compliance risks and opportunities.-Provide policy and compliance risk management guidance to the MAPS and Govt Affairs leadership teams to help ensure strategies and activities are consistent with business policies-Partner with the business in proactively identifying, assessing and managing risks including, those associated with commercial strategies and ensure effective business implementation of risk mitigation plans-Use a sensible, practical and risk-based approach in embedding effective compliance controls in business activities and processes-Develop and implement risk-based monitoring plans for commercial activities and identify trends and work with business stakeholders to implement corrective actions-Ensure that reports of suspected policy violations are addressed within the appropriate procedures

Lead PRA reviewer for, and instrumental in, the very successful cross-functional collaborations that enabled approval and launch of two new lung cancer drugs in 2015 – IRESSA and TAGRISSO, with TAGRISSO being an accelerated approval product with a companion diagnostic (carrying with it unique promotional challenges). In this role, Carla was responsible for the oversight and management of PRA staff for all Specialty Care ID and Oncology products.

Promotional Regulatory Affairs lead contributing to the success of-Launch of FluMist Quadrivalent for the 2013-14 influenza season which included an innovative consumer digital and social media and TV ad campaign-AZ's refocus in Oncology with refreshed Caprelsa Marketing Campaign balancing the business strategy and needs of Orphan Thyroid cancer treatment with its rigorous REMS program requirements and Faslodex growth trajectory and planning for additional indications-Lead team responsible for 2253 submission for Oncology and ID products in preparation for eCTD Module 1 Update to enable electronic 2253 submissions to OPDP

In 2008, Carla joined the Regulatory Ad/Promo team as a Associate Manager. Since then she has taken on increasing levels of responsibility and roles as the PRA Reviewer for various infectious disease promotional programs, and managing staff responsible for our OPDP and APLB submissions and processes. Highlights include: -Key expert and lead for both RSV and Flu promotional activities. -Significant contributions in the shaping of Synagis and FluMist commercial brand strategies and success of both brands in the marketplace as wells as internal success in establishing and managing the Promotions and Labeling Compliance Operations team.-Leadership during challenging AAP/COID guideline changes impacting Synagis promotion,-Managing innovative and industry-leading digital marketing campaigns for FluMist including Facebook, YouTube, broadcast, and iPad-based forms of communication-Lead the transition from paper to electronic 2253 submission over FDA ESG to APLB

-Responsible for the analysis and design of workflows and processes in/between RA and other departments-Represent RA in corporate project teams – global audits and inspections, clinical trial compliance, operational excellence, global registration tracking, post-marketing commitments and pharmacovigilance-Represented RA on internal regulatory inspection team and participated in multiple GMP and GCP focused inspections and audits-Identify policies and training programs to be developed (or revised) due to internal or external changes (inspection findings, new regulations or guidelines)-Regulatory submission experiences include: IND/NDA/BLA/eCTD submissions, IND amendments, BLA supplements, IND and BLA annual reports, post-marketing commitments reporting, Warning and Untitled Letter responses, advertising and promotional labeling and compliance related correspondence

-Applied knowledge of GLP regulations to contribute to the development and success of the CTL in the areas of assay validation, sample analysis, sample handling, materials management, documentation and equipment oversight -Instrumental in establishing Pharmacokinetic (PK) and Immunogenicity (IM) method SOPs and validation report templates, enabling expedited SOP and validation report writing and approval process-PK and IM Method validation reports contributed to multiple regulatory filings and submissions-Conducted analysis of clinical samples using ELISA format and completes appropriate documentation to support testing including data capture forms, equipment logbooks, laboratory notebooks, and reagent inventory forms-Trained in the usage of automated liquid handling robotics

-Primary responsibilities included: critical component testing, in-process testing, and final lot/batch approval, supervision of QC lab technicians and represented QA/QC in company production/project management meetings-Performed internal audits of company quality systems via lot record review, documentation audits, and performance audits of manufacturing and production groups-Performed, designed, and assessed testing procedures to evaluate performance to required specifications of company products-Testing experiences included ELISAs, immunoassays, antibody and protein characterization by isotyping, SDS-page, gel electrophoresis and purification by HPLC-Commercialization/ design changes of new and existing products