George Wagner Email and Phone Number

• Develop regulatory strategies to shorten product approval timelines and development of labeling• Oversight of the Quality Assurance and Pharmacovigilance functions • Lead regulatory clinical and CMC functions in strategizing and execution of clinical trials and manufacturing changes in support of ongoing development of processes• Liaise with domestic regulatory agencies

• Develop regulatory strategies to shorten product approval timelines and improve product labeling• Oversight of the pharmacovigilance function for post marketing and IND safety reporting• Lead regulatory CMC and clinical functions in strategizing and execution of additional clinical trials and manufacturing changes in support of new manufacturing processes and label indications• Liaise with domestic regulatory agencies • Managed teams in the preparation and conduct of multiple FDA meetings to advance drugs under development including Pre-IND, EOP2, and Pre-NDA meetings. • Management of the review and approval process for promotional and scientific communications

Local Anesthetics & Oncology ProductsResponsible for the strategic and day-to-day operation of Regulatory Affairs and Pharmacovigilance: • Develop regulatory strategies to shorten product approval timelines and improve product labeling• Management of the Pharmacovigilance function, both in-house and contracted services for approved and development products• Lead regulatory CMC and clinical functions in strategizing and execution of additional clinical trials and manufacturing changes in support of new manufacturing processes and label indications• Liaise with domestic and international regulatory agencies • Management of the review and approval process for promotional and scientific communications• Oversight of Drug Listing, Establishment Registration, User Fees, Wholesale Distributor Licensing, and Adverse Event Reporting.

Cardiovascular ProductsResponsible for the strategic and day-to-day operation of the Regulatory Affairs department: • Conducted regulatory due diligence evaluations on all business development opportunities.• Worked with Clinical and Commercial to develop target product profile, clinical development plans and protocols for in-house development projects.• Revised all EKR Sales, Marketing & Medical Affairs compliance policies.• Developed compliance programs for training and monitoring Sales, Marketing & Medical Affairs• Regulatory oversight of promotional review process• Oversight of Drug Listing, Establishment Registration, User Fees, State Aggregate Spend Reporting, State Sales Representative Licensing, Wholesale Distributor Licensing, and Adverse Event Reporting.

A senior member of the Regulatory Affairs function at a global consulting group. Projects included preclinical assessments, clinical trial design, labeling review, regulatory strategy, GCP assessments, and the implementation, validation and oversight of a new electronic CTD submission system.

Director, Regulatory Affairs – Opioid & NSAID Products Head of the regulatory affairs function for the Pharmaceutical Division; responsible for the strategic and day-to-day operation of the department. Regulatory responsibility for the Clinical, CMC, Labeling and Compliance aspects of projects including new product development, marketed products, OIG compliance, and business development evaluations. Member of the Alpharma Brand Leadership Team, which established goals and priorities for the division.• Grew department from one to ten professionals, enabling 'in-sourcing' of multiple regulatory functions and ability to address rapid growth in product and business development activities.• Key contributor to the clinical development program for the anti-abuse EMBEDA Capsules project, including co-authorship on publications, posters and abstracts. • Conducted regulatory due diligence evaluations on in-licensing opportunities, which led to the acquisition of FLECTOR Patch (1st approved topical NSAID patch) and DIRACTIN Gel (topical NSAID gel in development).• Regulatory oversight of all policy, training and monitoring for federal and state compliance of Sales, Marketing, Clinical and Medical Affairs departments, enabling the company to speak with a consistent compliance message.• Managed teams in the preparation and conduct of multiple FDA meetings to advance drugs under development including Pre-IND, EOP2, and Pre-NDA meetings. • Developed company-wide processes and procedures for the development, review and approval of all labeling, promotional materials and publications, which ensured the consistent, compliant messaging of our products.

Global Clinical Scientist – Oncology ProductsManaged clinical operations for late stage development of new indications for TAXOTERE Injection. Coordinated Clinical, Regulatory and Project Management efforts in finalizing clinical development programs, regulatory filings and approvals. Assisted Global Clinical Directors in completing pivotal phase 3 trials, writing clinical study reports and summary documents, and coordinating electronic submissions.• Established a new role within the Clinical Department which encompassed aspects of clinical, regulatory affairs and project management to facilitate the submission and approval of multiple indications for TAXOTERE Injection.• Managed global teams of clinicians, statisticians, data management, medical writing and regulatory affairs that achieved approval for three new indications for TAXOTERE Injection in breast adjuvant, non-small cell lung, and prostate cancers, growing it from a $400M to a $1B product.