Manager, Regulatory Affairs – Global Labeling

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

📋 Description

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

• Spearhead the global labeling initiative with a primary emphasis on US FDA standards and labeling requirements.

• Provide essential labeling insights for development programs, lifecycle management tasks, and regulatory submissions.

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

• Oversee the preparation and evaluation of US labeling materials, including USPI and updates to FDA labeling.

• Assist in interactions with the FDA and engage in labeling negotiations.

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

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

• Simplify complex regulatory requirements into actionable business recommendations.

• Support labeling governance procedures and ensure documentation is inspection-ready.

• Promote timely execution of labeling modifications and foster continuous process enhancements.

• Contribute to the development of labeling metrics, systems, and best practices.

• Assist with the creation, upkeep, version control, and change management of CCDS.

• Coordinate with global regulatory leads and regional Regulatory Affairs teams on local implementation needs.

• Record regional deviations or exceptions from CCDS and maintain justifications.

• Monitor labeling modifications across US and global markets, including milestones, dependencies, approvals, exceptions, and closure status.

• Maintain labeling trackers, action logs, decision records, and implementation updates.

⛳️ Requirements

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

• In-depth understanding of FDA labeling criteria.

• Proven experience in supporting US regulatory submissions.

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

• Capacity to influence cross-functional teams and oversee intricate projects.

• Exceptional written and oral communication abilities.

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

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

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

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

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

• GE HealthCare does not sponsor employment visas.

• Successful completion of a drug screening, where applicable.

• Some clients may enforce vaccination mandates for specific employees.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Paid time off

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

• Life insurance

• Disability insurance

• Accident insurance

• Tuition reimbursement

• Opportunities for professional development

• Competitive salary

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

• Relocation assistance not offered