Manager, Regulatory Affairs – Global Labeling

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate and implement global labeling strategies for designated PDx products.

• Oversee US FDA labeling initiatives and manage US Prescribing Information.

• Offer labeling insights for development programs, lifecycle management efforts, and regulatory submissions.

• Ensure consistency among US labeling, CCDS, and regional implementation strategies.

• Draft and evaluate US labeling content, including USPI and updates to FDA labeling.

• Assist in FDA interactions and engage in labeling negotiations.

• Evaluate regulatory risks and relay the implications of FDA feedback on development and commercialization strategies.

• Collaborate with Clinical, CMC, Safety, Medical, Market Access, Commercial, Legal, Ad Promo, global Regulatory Affairs, and regional Regulatory Affairs teams.

• Convert intricate regulatory requirements into actionable business recommendations.

• Aid in labeling governance processes and guarantee documentation is inspection-ready.

• Propel prompt execution of labeling modifications and foster continuous process enhancements.

• Contribute to labeling metrics, systems, and best practices.

• Assist in the creation, maintenance, version control, and change-control of CCDS.

• Liaise with global regulatory leads and regional RA teams regarding local implementation necessities and regional variances.

• Monitor the execution of labeling changes across US and international markets.

• Sustain labeling trackers, action logs, decision records, and implementation status for global transparency and inspection preparedness.

⛳️ Requirements

• Over 7 years of experience in Regulatory Affairs, particularly in labeling.

• In-depth understanding of FDA labeling regulations.

• Proven experience supporting US regulatory submissions.

• Background in developing and upkeeping US labeling and/or CCDS.

• Capability to influence cross-functional teams and handle intricate projects.

• Exceptional written and verbal communication skills.

• Experience liaising with the FDA on labeling issues (preferred).

• Familiarity with EU and global labeling standards (preferred).

• Experience using Veeva RIM or comparable regulatory systems (preferred).

• Degree in Life Sciences, Pharmacy, or a related discipline (preferred).

• Must possess legal authorization to work in the United States.

• GE HealthCare will not sponsor employment visas, either now or in the future.

• Successful completion of a drug screening may be required.

• Certain GE HealthCare employees may be subject to specific customer vaccination mandates.

🏝️ Benefits

• Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI).

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Paid time off.

• 401(k) plan with opportunities for employee and company contributions.

• Life insurance.

• Disability insurance.

• Accident insurance.

• Tuition reimbursement.

• Opportunities for professional development.

• A positive work environment.

• Engaging and challenging careers.

• Competitive compensation.