Specialist - Regulatory Submissions Management

Posted 6 Days Ago
Be an Early Applicant
Hiring Remotely in USA
Remote
62K-94K Annually
Junior
Artificial Intelligence • Healthtech • Analytics • Biotech
The Role
Provides regulatory submission publishing and management services using Veeva systems. Plans and tracks submissions, supports Regulatory Affairs and local affiliates, coordinates global work-sharing, and advises on document management and submission-ready standards. Monitors regulatory guidance, resolves day-to-day issues, and supports improvements to publishing tools, standards, and processes.
Summary Generated by Built In
Job Description SummaryAs a Publishing Specialist within the Regulatory Submissions Management team, you will be responsible for providing regulatory submission publishing services in an efficient and timely manner. This role is a key point of contact for all customers of the Regulatory Operations group; and upholds “right first time” submission quality and timeliness. Your work will perform a pivotal role in achieving GE Healthcare’s Regulatory Strategies.

Job Description

Responsibilities: 

  • Use Veeva for Registrations to plan and track your assigned submissions and effectively manage own workload 

  • Liaise with Regulatory Affairs and local affiliates to provide them with 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 the publishing tools, standards, and processes 

  • Monitor agency guidance & changing regulations in assigned region 

 Required Qualifications: 

  • 1+ year of Submission Publishing and Submission Management principles is preferred, with some knowledge of formats, standards, and processes in your assigned region 

  • Some hands-on experience with Submission Publishing, Validation and PDF manipulation software as well as Document Management and RIM systems (e.g., Veeva Vault) an advantage 

Desirable Skills: 

  • 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 an advantage 

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 $62,400.00-$93,600.00 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

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

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.

Relocation Assistance Provided: No

Application Deadline: September 25, 2026

Skills Required

  • 1+ year of experience with submission publishing and submission management principles
  • Knowledge of submission formats, standards, and processes in the assigned region
  • Hands-on experience with submission publishing, validation, and PDF manipulation software
  • Experience with document management and RIM systems, such as Veeva Vault
  • Good interpersonal skills and ability to engage effectively with peers
  • Ability to resolve day-to-day issues and escalate when necessary
  • Good IT skills and ability to learn new tools and systems quickly
  • Experience working with outsource partners

GE Healthcare Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.

  • Healthcare Strength Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
  • Retirement Support Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
  • Strong & Reliable Incentives Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.

GE Healthcare Insights

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The Company
HQ: Chicago, IL
50,282 Employees
Year Founded: 1892

What We Do

Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.

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