Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls

🕒 Yesterday

🇺🇸 United States – Remote

💵 $106.4k - $159.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

🏢 Enterprise

💰 $1.2G Post IPO secondary on 2024-12

Healthcare • Enterprise

GE HealthCare is a global healthcare technology company focused on developing products, technologies, and solutions that improve patient care and healthcare delivery. The company emphasizes innovation, next-generation solutions, and improving wellbeing worldwide. It operates in many countries (offices in 80 countries) and offers career opportunities across early careers and professional roles. GE HealthCare communicates a mission to make healthcare better and champions employee wellbeing, diversity, and equal opportunity.

📋 Description

• Provide CMC-related strategic regulatory input for assigned projects and products • Build or contribute to submission strategy documents, defining variation type, supporting data, and required submission documents • Review and approve published submission output • Guide project teams with the Global Regulatory Lead during project planning to ensure appropriate data and detail are collected for all markets • Review, write, and edit CMC submission documents and dossier sections • Maintain registration tracking information • Assist in developing good document management practice standards • Collaborate with global and regional Regulatory Affairs teams to address regulatory authority questions • Provide proactive CMC regulatory advice and assess impact on product dossiers for key brand CMC variations • Advise project teams on CMC regulatory matters • Support Quality Assurance during audits and inspections • Stay current on CMC-related guidelines

🎯 Requirements

• Bachelor's Degree and 6+ years of experience • Experience in a diagnostic, pharmaceutical, or medical device industry • Ability to prioritize, plan & evaluate deliverables to established strategic goals • Demonstrated experience operating in a highly regulated environment • Analytical skills in a CMC regulatory environment • Knowledge and experience in a scientifically related field, such as pharmaceutical sciences, chemistry, and analytical sciences • Experience with electronic document management and Quality management systems • Knowledge of international CMC regulatory requirements • Must be legally authorized to work in the United States • Must not require employment visa sponsorship now or in the future • Successful completion of a drug screen, as applicable • Master's Degree preferred • Experience in pharmaceutical CMC regulatory or QA environment, particularly injectable diagnostic or pharmaceutical products, preferred • Experience working within a matrix organization and strong interpersonal and influencing skills preferred • Experience with Veeva RIM or other registration tracking tools preferred • Experience prioritizing conflicting demands from multiple business entities in a fast-paced environment preferred • Strong problem-solving and negotiation skills preferred

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Paid time off • 401(k) plan with employee and company contribution opportunities • Life insurance • Disability insurance • Accident insurance • Tuition reimbursement • Professional development • Competitive compensation • Performance-based incentive compensation, potentially including cash bonuses and long-term incentives (LTI)

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