Manager, Regulatory Affairs, Strategic Global Labeling (Office-based)

Role Summary

The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing and delivering patient-centered global product labeling for the safe and effective use of AbbVie products. The role involves leading cross-functional teams to develop comprehensive label strategies and create accurate labeling for development and marketed products, ensuring compliance with company procedures and applicable regulations.

Responsibilities

• Develop and maintain target labeling and prescribing information, including company core data sheets, and US and EU labeling documents, through the product lifecycle. Make recommendations to proactively optimize labeling language, including effective use of target labeling as applicable, for assigned products. Product portfolio will include pharma, OTC, and/or device or combination products.
• Lead cross-functional labeling teams to develop comprehensive label strategies and create accurate labeling for development and marketed products by understanding supporting data and leveraging knowledge of labeling regulations, precedent, and company processes to guide strategy and content development.
• Lead cross-functional team discussion of safety-related labeling changes and process the labeling in accordance with internal labeling procedures.
• Maintain documentation within regulatory information management system.
• Co-lead cross-functional labeling and regulatory strategy team (with guidance).
• Provide guidance to affiliates on labeling proposals and responses to health authorities.
• Present/communicate labeling strategies and decisions to senior and executive leadership.
• Represent the department on cross-functional regulatory and safety teams; contribute to and review regulatory and safety documents for labeling content.
• Contribute to or lead departmental or cross-functional process improvement initiatives.

Qualifications

• Required Education: Bachelor‚Äôs degree in Pharmacy, Biology, Chemistry, Pharmacology or related subject. Preferred Education: Advanced degree. Certifications a plus
• Required Experience: 6 years in Pharmaceutical, regulatory, R&D or industry related area. Experience in labeling or area that could link to labeling. Preferred Experience: 3 years in pharmaceutical or regulatory preferred. Minimum 3 years‚Äô experience in clinical or pharmaceutical preferred
• Strong communication, collaboration, time management, and problem-solving skills.
• Proactive, able to manage multiple projects simultaneously, and set daily priorities. Able to work in a complex and matrixed environment.
• Ability to lead live or virtual meetings and document team decisions.
• Note: Higher education may compensate for years of experience
• This role will work a hybrid work schedule (3 days in office) from the Irvine, California headquarters.

Skills

• Demonstrated ability to lead cross-functional teams
• Strong strategic thinking and labeling knowledge
• Effective communication with senior and executive leadership
• Regulatory information management and documentation capabilities