Project Management Quality Assurance
Resume:
DEBORAH PANNELL
Pharmaceutical Administrator and Operations Professional
Rego Park, NY 11374 ***********@*****.***
PROFILE SUMMARY
Results-driven Pharmaceutical Administrator and Operations Professional with extensive experience in global labeling management and compliance, and cross-functional project management. Proven expertise in developing and implementing labeling strategies for ANDA, NDA, and global drug products. Skilled in managing high-volume SKUs, ensuring FDA compliance, and leading global teams. Adept at streamlining processes, improving efficiency, and maintaining meticulous attention to detail in fast-paced environments. A collaborative leader with strong written, verbal, and interpersonal communication skills, capable of driving operational excellence and achieving organizational goals. CORE COMPETENCIES & PROFESSIONAL CONTRIBUTIONS
Regulatory Labeling Expertise: Developed and reviewed labeling documents for ANDA, NDA, and global submissions, ensuring FDA compliance and accuracy. Provided guidance on labeling regulations to support successful product approvals. Develop and implement IFU’s for commercial packaging and marketing requirements.
Cross-Functional Collaboration: Partnered with teams, contract packagers, and internal departments to implement labeling changes and streamline processes. Facilitated meetings to align stakeholders on updates.
Project Management: Led high-impact projects, including change control management and barcoding initiatives, improving operational efficiency. Managed timelines and deliverables to ensure seamless execution of labeling initiatives.
Compliance & Quality Assurance: Ensured all labeling documents met regulatory standards and supported successful Health Authority submissions. Conducted audits and reviews to maintain document integrity and adherence to guidelines.
Process Optimization: Streamlined labeling workflows, reducing errors and improving turnaround times for commercial and submission labeling. Implemented automation tools to enhance efficiency and accuracy.
Team Leadership: Developed and mentored cross-functional teams, fostering collaboration and knowledge sharing across departments. Provided training sessions to enhance team expertise in labeling compliance.
Technical Proficiency: Utilized tools like Veeva, Documentum, and Adobe to manage labeling documents and ensure compliance. Maintained database accuracy and optimized digital workflows for regulatory submissions. SKILLS HIGHLIGHTS
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Regulatory Labeling & Compliance
ANDA & NDA Labeling Submissions
Change Control Management
Cross-Functional Team Leadership
Technical Writing & Documentation
Pharmaceutical and Medical Device
experience
SharePoint & Trackwise
TVT/DocuProof/GlobalVision
Attention to Detail & Accuracy
Interpersonal & Communication Skills
Multitasking & Deadline Management
MS Office, Veeva, Documentum, Adobe
FDA & Global Compliance
Process Improvement & Optimization
Project Management & Coordination
Electronic Verification & Validation
PROFESSIONAL WORK EXPERIENCES
Avet Pharmaceuticals, Inc
Global Labeling Lead
January 2024 – September 2024
Led labeling efforts for 200+ SKUs, ensuring compliance with FDA and global Health Authority standards. Collaborated with contract packagers to implement labeling changes and streamline processes.
Developed and reviewed labeling documents for ANDA and NDA submissions, ensuring accuracy and compliance.
Maintained Regulatory Labeling Tracker to monitor progress and ensure timely submissions.
Created draft labeling for submission and commercial use, adhering to FDA requirements.
Reviewed and approved labeling revisions, ensuring compliance with regulatory standards.
Collaborated with global teams to implement labeling changes for contract packagers.
Streamlined labeling workflows, reducing errors and improving turnaround times.
Ensured all labeling documents met FDA and global Health Authority standards. Bausch Health, Actalent Contract Employee
Global Labeling Lead
June 2023 – January 2024
Managed labeling for generic and branded products, ensuring compliance with FDA and submission requirements. Collaborated with cross-functional teams to implement labeling changes.
Reviewed and approved drug labeling for FDA submissions and commercial use.
Developed labeling strategies for generic and branded products, ensuring compliance.
Collaborated with internal teams to implement labeling changes and streamline processes.
Ensured all labeling documents met FDA and global Health Authority standards.
Streamlined labeling workflows, reducing errors and improving turnaround times.
Supported cross-functional teams in implementing labeling changes and ensuring compliance.
Maintained accurate records of labeling changes and submissions.
Worked with Regulatory Ops and Marketing teams to create and submit Smpc documents. Bristol Myers Squibb, Hiregenics Contract Employee Global Labeling Lead
July 2022 – February 2023
Reviewed and approved drug labeling documents for FDA and global submissions, ensuring compliance with regulatory standards. Verified content and labeling design using validated software tools to maintain accuracy and consistency.
Reviewed and approved labeling documents for FDA and global submissions.
Verified content and labeling design using validated software tools.
Proofread package inserts, SPLs, and printed packaging components.
Ensured all labeling documents met FDA and global Health Authority standards.
Collaborated with cross-functional teams to implement labeling changes.
Streamlined labeling workflows, reducing errors and improving turnaround times.
Maintained accurate records of labeling changes and submissions. Labeling Associate, Level 4
Sandoz Inc., a Novartis Corporation March 1985 – July 2022 Developed labeling documents for new and legacy products, ensuring compliance with FDA and global Health Authority standards. Supported cross-functional teams in implementing labeling changes.
Developed labeling documents for new and legacy products, ensuring compliance.
Prepared labeling documents for submission to Health Authorities.
Developed SPLs for approved and pending products, adhering to FDA formats.
Implemented labeling documents for commercial use, ensuring compliance.
Supported cross-functional teams in implementing labeling changes and ensuring compliance.
Streamlined labeling workflows, reducing errors and improving turnaround times.
Maintained accurate records of labeling changes and submissions. KEY ACHIEVEMENTS
Spearheaded labeling for 200+ SKUs, ensuring compliance and timely submissions for ANDA and NDA products.
Streamlined labeling workflows, reducing errors and improving turnaround times for commercial and submission labeling.
Led global projects for change control management, enhancing operational efficiency and compliance.
Developed and implemented labeling strategies for contract packagers, ensuring seamless production and distribution.
Mentored cross-functional teams, improving collaboration and knowledge sharing across departments. EDUCATION
Bachelor of Arts in Economics
Rutgers University 1975
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