Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $106.4k - $159.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 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