Cmc Program Manager Jobs in Minnesota (NOW HIRING)

Job Description SummaryThe Senior Director of Regulatory Affairs, Radiopharma serves as a senior global leader within the Pharmaceutical Diagnostics (PDx) Regulatory Affairs organization, reporting into the Global Head of Regulatory Affairs. This role provides end to end regulatory leadership across drug development, registration, lifecycle management, compliance, and CMC for key markets including the United States, while supporting global regulatory strategy, governance, and operational excellence. The Senior Director leads a multi regional team of global regulatory professionals and partners closely with regulatory regional teams and the cross functional leaders to advance the PDx product portfolio efficiently and compliantly.Job Description

Key Responsibilities

1. Global Regulatory Strategy & Execution

• Develop, oversee and drive global regulatory strategies for assigned development programs and marketed products in US, and other priority markets supported by the regional regulatory teams, ensuring alignment with business objectives, regional requirements, and longterm portfolio plans.
• Provide strategic guidance from early development to registration and lifecycle, leveraging expertise across CMC, nonclinical, clinical, and quality domains.
• Monitor and interpret global regulatory trends, emerging guidances, and agency expectations to inform program design and risk mitigation strategies.

2. Health Authority Engagement & Advocacy

• Serve as the senior regulatory lead in interactions with major health agencies including FDA, leading highstakes negotiations and ensuring highquality briefing packages and responses.
• Represent the organization in global regulatory forums and external industry groups to influence evolving regulations and advocate for PDxrelevant policy positions.

3. CrossFunctional & Global Program Leadership

• Partner with R&D, CMC, Manufacturing, Clinical, Medical, Quality, Commercial, and Supply Chain teams to integrate regulatory requirements into global product strategies, development plans, and launch readiness.
• Communicate effectively opportunities and risks of proposed regulatory strategies.

4. Team Leadership & Organizational Development

• Lead, mentor, and develop a global team of regulatory professionals across multiple regions, ensuring clear priorities, proper resource allocation, and highquality, timely execution.
• Foster a culture of compliance, agility, scientific excellence, and proactive problem-solving, consistent with the expectations for senior leadership roles.

5. Regulatory Governance, Compliance & Quality Systems

• Ensure global compliance across development, submissions, registration maintenance, and postmarket activities.
• Oversee preparation, accuracy, and maintenance of global regulatory dossiers, ensuring alignment across regions and adherence to corporate governance expectations.
• Lead continuousimprovement initiatives to enhance regulatory efficiency, operational excellence, and risk management.

6. Business Partnership & Strategic Support

• Support due diligence activities for partnerships, acquisitions, and inlicensing opportunities by assessing regulatory risks, pathways, and development strategies.
• Contribute to regulatory budgeting, longrange planning, and strategic portfolio prioritization.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree strongly preferred.
• 12+ years of global regulatory affairs experience, including leadership roles with increasing responsibility.
• Demonstrated success supporting or leading regulatory strategy and submissions in US, and other highly regulated agencies such as in Japan, China and in EU, across development, approval, and lifecycle phases.
• Proven experience navigating US FDA requirements, regulations and pathways including but not limited to experience with Fast Track, Orphan Designation, Priority and Rolling Review, etc.
• Strong expertise in Clinical and CMC regulatory strategy, with handson experience guiding Clinical and CMC teams through development, registration, and global change management.
• Proven experience managing and developing regulatory teams across multiple regions.
• Deep understanding of global regulatory frameworks from IND/CTA through marketing approval, postapproval changes, compliance, and pharmacovigilancerelated requirements.

Preferred / Desired Characteristics

• Experience in sterile injectables, diagnostics, or radiopharmaceuticals.
• Excellent strategic thinking, systemslevel problemsolving, and decisionmaking abilities.
• Strong communication and negotiation skills, with ability to influence executives and regulators.
• Excellent project management and organization skills; capable of leading multiple complex programs simultaneously.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $198,000.00-$297,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Application Deadline: July 09, 2026