Regulatory Submissions Management Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Utilize Veeva for Registrations to organize and monitor assigned submissions while managing workload efficiently.

• Collaborate with Regulatory Affairs and local affiliates to deliver Submissions Management and provide hands-on support for Submissions Publishing.

• Coordinate with Regulatory Submissions Management teams in other regions to promote global work-sharing initiatives.

• Offer clients best practice recommendations in Submission Publishing, Document Management using Veeva Vault, and standards for submission-ready documents.

• Assist in projects aimed at enhancing publishing tools, standards, and processes.

• Keep track of agency guidance and evolving regulations within the assigned region.

• Act as a primary point of contact for the customers of the Regulatory Operations group.

• Maintain high standards of submission quality and timeliness, adhering to the “right first time” principle.

⛳️ Requirements

• A minimum of 1 year of experience in Submission Publishing and Submission Management principles is preferred.

• Familiarity with formats, standards, and processes relevant to your assigned region is beneficial.

• Practical experience in Submission Publishing, Validation, and PDF manipulation software is required.

• Experience with Document Management and RIM systems, such as Veeva Vault, is an advantage.

• Strong interpersonal skills with the ability to engage effectively with colleagues.

• Capability to resolve most daily issues, seeking assistance from peers and/or supervisors when necessary.

• Proficient IT skills with a quick learning ability for new tools and systems.

• Experience collaborating with outsource partners is a plus.

• Employment visa sponsorship is not available now or in the future.

• Must possess legal authorization to work in the United States.

• Successful completion of a drug screening may be required (as applicable).

• Certain GE HealthCare customers may have vaccination mandates applicable to specific GE HealthCare employees.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Paid time off.

• 401(k) plan with options for employee and company contributions.

• Life, disability, and accident insurance.

• Tuition reimbursement.

• Professional development opportunities.

• Competitive compensation.

• Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI).