Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls

Job 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 during planning so appropriate data and detail for all markets are collected and submitted
• Review, write, and edit CMC submission documents and dossier sections
• Maintain registration tracking information and support good document management practice standards
• Collaborate with global and regional Regulatory Affairs teams to address regulatory authority questions
• Provide regulatory advice and assess product dossier impact 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 pharmaceutical sciences, chemistry, and analytical sciences
• Experience with electronic document management and Quality management systems
• Knowledge of international CMC regulatory requirements
• Experience in pharmaceutical CMC regulatory or QA environment, particularly injectable diagnostic or pharmaceutical products
• Experience working within a matrix organization
• Experience with Veeva RIM or other registration tracking tools
• Strong problem-solving and negotiation skills
• Legally authorized to work in the United States; GE HealthCare will not sponsor employment visas
• Successful completion of a drug screen, as applicable

Benefits:

• Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
• Medical, dental, and vision insurance
• Paid time off
• 401(k) plan with employee and company contribution opportunities
• Life, disability, and accident insurance
• Tuition reimbursement
• Professional development
• Relocation assistance not provided