Sr Global Regulatory Associate (eCTD Publishing) at Fresenius Medical Care

Waltham, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Medical DevicesIndustries

Requirements

Serves as a seasoned regulatory operations professional with a comprehensive understanding of global submission requirements and processes
Demonstrates strong organizational and time management skills with the ability to manage multiple priorities under tight deadlines
Proficiency in troubleshooting technical issues related to publishing tools and document formatting, particularly within MS Word and Adobe Acrobat
Ability to interpret and apply key regulatory guidance, regional submission specifications, and evolving eCTD requirements (including ICH, FDA, EMA, etc.)
Experience in evaluating and implementing new regulatory technologies and supporting transitions from legacy systems to electronic platforms
Capability to mentor junior staff and act as a resource for complex submissions

Responsibilities

Manages the end-to-end preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD) in compliance with global Health Authority requirements and internal standards
Supports submission planning and execution for initial marketing applications and post-approval lifecycle submissions (e.g., supplements, variations, renewals) across multiple regions including the U.S., Canada, EU, and Asia-Pacific
Performs thorough QC reviews to ensure submission-ready documents meet formatting, technical, and regulatory standards
Collaborates cross-functionally with Regulatory Affairs, CMC, Medical Writing, Quality, and other stakeholders to ensure timely and accurate handoff of components for inclusion in submissions
Leads and contributes to the development, revision, implementation, and training of departmental SOPs, WIs, and standardized publishing processes to ensure consistency, efficiency, and regulatory compliance
Assists in the management and continuous improvement of templates, procedures, and tools used to support global submission activities
Troubleshoots technical issues related to publishing tools and document formatting, and supports resolution of validation errors
Participates in evaluating and implementing new regulatory technologies; ensures alignment with infrastructure standards
Maintains compliant archival and storage of regulatory documents, ensuring alignment with regulatory and business needs
Ensures compliance with all applicable regulations, company policies, and the Code of Business Conduct
May escalate complex issues for resolution and assist with additional projects or duties as assigned
Assist with various projects as assigned by a direct supervisor

Skills

eCTD Publishing

eCTD

Regulatory Submissions

SOPs

Work Instructions

Quality Control

Validation

Global Regulatory Requirements

Submission Planning

CMC

Document Management

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Waltham, MassachusettsHeadquarters

1996Year Founded

$39.1MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

11-50Employees

Benefits

Professional Development Budget

Conference Attendance Budget

Flexible Work Hours

Risks

Increased competition from telehealth solutions like Philips' eCareManager 4.1.

Rising mental health challenges may impact FMCNA's employee productivity.

Virtual reality education may face adoption and accessibility challenges in rural areas.

Differentiation

FMCNA is the world's largest fully integrated renal company.

FMCNA offers a comprehensive line of dialysis equipment and renal pharmaceuticals.

FMCNA provides coordinated healthcare services at pivotal care points for chronic conditions.

Upsides

Telehealth market growth supports FMCNA's remote patient monitoring services.

Home dialysis market expansion aligns with FMCNA's patient-centric care approach.

AI integration enhances FMCNA's predictive analytics and personalized medicine capabilities.

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