Regulatory Operations Labeling Manager

Description

• Label Development:
• Represent RO Labeling during NNI - Local Labeling Committee (LLC) and HQ – Product Labeling Council meetings and communications, ensuring accurate reconciliation and incorporation of comments into draft labels in collaboration with responsible TA personnel
• Drive the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on-time launch of product labeling per company launch readiness timelines
• Ensures additional filing requirements are completed for approved content of labeling to include SPL drug Listing, FDA 2253s and Puerto Rico Registrations
• Labeling Tools:
• Serve as a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault, Esko, Acrobat, etc.) coordinating technical support needs with internal IT groups
• Utilizing FDA portals and tools to include WebTrader, CDER NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinating with agencies to resolve any issues
• Regulatory Support:
• Act as a resource for colleagues, providing guidance, training, and mentorship, while contributing to the development of new concepts, standards, and techniques in labeling operations
• Participate in cross-functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity
• Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations
• Actively participate in industry meetings and conferences to stay abreast of regulatory developments and industry trends
• Skills and Experience:
• Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected Requirements of Prescribing Information, FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry-standard labeling trends, DUNS, and FEI Registrations
• Excellent communication, collaboration, and interpersonal skills to work effectively with cross-functional teams and key company personnel
• Strong problem-solving abilities with a keen attention to detail and adherence to federal requirements and best practices
• Proven ability to independently manage labeling processes, prioritize tasks, and drive successful outcomes

Qualifications

• A Bachelor's Degree Required; relevant experience may be substituted for degree, when appropriate and is dependent on the requirements of the position
• A minimum of 6 years progressively responsible, relevant experience, with a concentration in labeling development and lifecycle management
• An experienced professional having a wide range of patient label development and final printed label knowledge to include a complete understanding of regulatory labeling operations roles and responsibilities
• Demonstrates full knowledge of industry practices and standards related to labeling, product listings and establishment registrations
• Demonstrated ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status
• Proficiency with Microsoft Office, Veeva Vault(s), A4L, ALiCE, and TVT
• Excellent verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast-paced, team environment consisting of local and global team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects