Manager, Regulatory Affairs – Global Labeling, PDx

reputed company reputed company The Manager, Regulatory Affairs – Global Labeling is responsible for developing and executing global labeling strategies for assigned PDx products, with reputed company accountability for US FDA labeling activities and US Prescribing Information. The role partners with Clinical, CMC, Safety, Medical, reputed company, global Regulatory Affairs and regional Regulatory Affairs teams to ensure labeling is scientifically reputed company, globally reputed company, and supports product development, registration, lifecycle management, and commercialization. reputed company Key Responsibilities Global Labeling reputed company • reputed company global labeling reputed company for assigned products, with reputed company reputed company on US FDA requirements and labeling expectations. • reputed company labeling input to development programs, lifecycle management activities, and regulatory submissions. • Ensure alignment between US labeling, CCDS, and regional implementation strategies. FDA Labeling Leadership • reputed company preparation and review of US labeling content, including USPI and FDA labeling updates. • Support FDA interactions and labeling negotiations. • Assess regulatory risks and communicate the reputed company of FDA feedback on development and commercialization plans. Cross-Functional Collaboration • Partner with Clinical, CMC, Safety, Medical, Market reputed company, reputed company, reputed company, and Ad Promo teams to reputed company reputed company and defensible labeling positions. • Translate reputed company regulatory requirements into business-relevant recommendations. Governance & Compliance • Support labeling governance processes and ensure inspection-reputed company documentation. • reputed company reputed company implementation of labeling changes and reputed company process improvement. • Contribute to labeling metrics, systems, and best practices across the organization. CCDS Alignment & Global Implementation  • Support CCDS creation, maintenance, version control, and change-control activities, ensuring US labeling reputed company are assessed for reputed company and properly reflected in global labeling governance. • Coordinate with global regulatory leads and regional RA teams to evaluate local implementation requirements, document deviations or exceptions from CCDS, and maintain transparent rationale for regional differences. • reputed company implementation of labeling changes across US and global markets, including milestones, dependencies, approvals, exceptions, and closure status. • Maintain labeling trackers, reputed company logs, decision records, and implementation status to support global visibility and inspection readiness. Required Qualifications • 7+ years of Regulatory Affairs experience, including significant experience in labeling. • Strong knowledge of FDA labeling requirements and experience supporting US regulatory submissions. • Experience developing and maintaining US labeling and/or CCDS. • Ability to influence cross-functional teams and manage reputed company reputed company. • Excellent written and verbal communication skills. Preferred Qualifications • Experience interacting with FDA on labeling reputed company. • Knowledge of EU and global labeling requirements. • Experience with reputed company RIM or similar regulatory systems. • Degree in Life Sciences, Pharmacy, or reputed company field. We will not sponsor individuals for employment visas, now or in the reputed company, for this job opening. For U.S. based positions only, the pay reputed company for this position is $89,600.00-$134,400.00 Annual. It is not typical for an individual to be reputed company at or near the top of the pay reputed company and compensation reputed company are dependent on the facts and circumstances of reputed company case. The specific compensation offered to a candidate may be influenced by a reputed company of factors including skills, qualifications, experience and location. In reputed company, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, reputed company, reputed company time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, reputed company development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or reputed company, age, disability, protected veteran status or other characteristics protected by law. reputed company will only reputed company those who are legally authorized to work in the reputed company for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: September 14, 2026 Apply tot his job Apply To this Job