Deborah Goff Email & Phone Number

Greenville, Nc, Us

Tarrytown, New York, Us

• Manage the development, revision, preparation and internal approval of packaging artworks e.g., carton, container label, printed package inserts for assigned development products as well as marketed products. Maintain a strong understanding of industry labeling trends related to packaging and labeling content and implementation, reviewing competitor and other labeling. Interpret labeling regulations and guidance, determine company impact and provide direction, as appropriate.• Provide functional expertise at relevant department meetings and relevant cross functional sub-teams.• Lead packaging team to ensure packaging content and artworks are compliant with internal labeling policies, standard operating procedures and worldwide health authority regulations.• Contribute and manage Annual Reports for assigned products.• Maintain and track packaging artwork lifecycle and documents in appropriate labeling repository and electronic systems.• Manage and review preparation of SPL.• Perform/manage proofreading as requested by Labeling Lead.• Monitor the worldwide regulation changes pertaining to Labeling regulations and author the maintenance of the labeling SOP and work instructions.• Assist labeling staff and other sub-team members in labeling operations project and process management to build expertise and awareness.• Independently determines methods and procedures on new assignments and coordinates activities/providing technical guidance to others.• Work independently across multiple areas.

Raleigh, North Carolina, Us

• Provided labeling operations expertise, leadership and guidance to internal and external stakeholders in the successful development, submission, and implementation of CCDS, US and EU labeling.• Implemented internal or client procedures, processes or programs that resulted in continuous improvements for labeling activities and business requirements.• Worked cross-functionally to ensure client labeling objectives are met. Monitor progress, identify risks and propose solutions for improvements.• Formulated strategies for the submission and implementation of new and revised labeling.• Provided expert advice on current labeling requirements, industry trends, templates, tools, systems, medical and regulatory regulations and guidance documents.• Supported ICON/PRA and client activities associated with IT systems and technology.

Paris, France, Fr

Cambridge, Cambridgeshire, Gb

• Serve as Labeling Strategist, Lifecycle and US Labeling Delivery Manager for all authorized generic product development projects.• Responsible for the regulatory role as part of the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products and devices. • Author and trainer of authorized generics program for labeling creation and product launch. • Ensure all work is performed in accordance with established procedures and regulatory requirements. • Point of contact for the management of all labelling/artwork requests that require market/regulatory approval in US, (i.e., creation, approval, and implementation of commercial printed labeling in collaboration with various functions). • Coordinate and/or lead the development and lifetime maintenance of packaging component labeling for commercial products, including introduction of new packs and new product launches, updates to existing packs, and mock-ups for regulatory submissions. • Provide tactical and strategic guidance to product labeling teams regarding regulatory requirements for packaging component labeling.• Understand industry labeling trends related to packaging and labeling content and implementation, reviewing competitor and other labeling. • Interpret labeling regulations and guidance, determining company impact and providing comments as appropriate.• Contribute the regulatory labeling perspective in support of novel packaging design initiatives. • Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents. • Originate precedent searches, create and maintain labeling comparisons, and assist in analysis of competitive labeling. • Interact with Marketing Company colleagues regarding global artworks as appropriate. • Process and prepare all US Final Printed Labeling required for submission.

Basel, Basel-Stadt, Ch

• Managed end-to-end labeling compliance for the Sandoz Wilson manufacturing site from development of Core Data Sheets (CDS) to withdrawal of product from the FDA Orange Book.• Team leader of three labeling specialists. Managed workload assignments and provided labeling guidance.• Authored, implemented and maintained current labeling processes and procedures.• Collaborated with Regulatory Affairs Chemistry, Manufacturing, and Control (RA CMC) Associates regarding labeling changes for FDA submissions.• Advanced knowledge of current Good Manufacturing Practices (cGMPs), Structured Product Labeling (SPL), Code of Federal Regulations (CFRs), Track and Trace, electronic Common Technical Document (eCTD).• Authored FDA labeling submissions and submitted drug listings according to Code of Federal Regulations (CFR) requirements.• As Secretary, Change Agents Committee, supported site culture and Sandoz community involvement.

• Supervised Packaging Engineers in the acquisition of all packaging component artwork.• Coordinated development, approval and distribution of all packaging component artwork, proofs and color standards between outside graphics contractors, customers and suppliers for all existing drug products and new drug product launches.• Provided graphics creation support/typesetting to customers that require graphics services.• Effectively communicated with customers, suppliers, outside graphics contractors and internal departments to develop and approve artwork and quickly resolve issues regarding the artwork/proof process.• Acted as a knowledge resource in relation to regulatory guidelines pertaining to packaging graphics.• Prepared artwork for production and test packaging components using appropriate graphics software.• Thoroughly proofread and edited all packaging graphics per SOPs to ensure that they were complete, correct and in compliance with DSM Pharmaceuticals and external customer requirements and regulatory guidelines.• Created, monitored and prioritized timelines for the artwork development and approval process.• Reacted quickly to changing priorities to meet the needs of Marketing and Production schedules.• Performed pre-flight on all artwork created internally and externally before forwarding to suppliers to confirm that it was complete and correct.• Maintained center of records for all DSM Pharmaceuticals artwork.

Msa, Information Resources Management

R.A.C., Regulatory Affairs Certification

B.S., Business Administration: Organizational Development And Management

A.A.S, Business Administration