Regulatory Submissions Management Specialist

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $62.4k - $93.6k / year

⏰ Full Time

🟡 Mid-level

🟠 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

• Use Veeva for Registrations to plan and track assigned submissions and manage workload • Liaise with Regulatory Affairs and local affiliates to provide Submissions Management and hands-on Submissions Publishing support • Work with Regulatory Submissions Management counterparts in other regions to facilitate global work-sharing • Provide customers with best practice guidance within Submission Publishing, Document Management using Veeva Vault, and submission-ready document standards • Support projects related to improving publishing tools, standards, and processes • Monitor agency guidance and changing regulations in the assigned region • Serve as a key point of contact for customers of the Regulatory Operations group • Uphold “right first time” submission quality and timeliness

🎯 Requirements

• 1+ year of Submission Publishing and Submission Management principles is preferred • Some knowledge of formats, standards, and processes in your assigned region • Some hands-on experience with Submission Publishing, Validation and PDF manipulation software • Experience with Document Management and RIM systems (e.g., Veeva Vault) is an advantage • Good interpersonal skills and ability to engage effectively with peers • Ability to resolve most day-to-day issues, escalating to peers and/or supervisors as needed • Good IT skills, with the ability to learn new tools and systems quickly • Experience working with outsource partners is an advantage • Will not sponsor individuals for employment visas, now or in the future • Must be legally authorized to work in the United States • Successful completion of a drug screen (as applicable) • Some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees

🏖️ Benefits

• 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 • Competitive compensation • Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)