Fresenius Medical Care
Sr Global Regulatory Associate (eCTD Publishing)
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Job Description
- Req#: R0208010
Employer Industry: Pharmaceutical Regulatory Operations
Why consider this job opportunity:
- Minimum of five (5) years of regulatory operations experience in the pharmaceutical or biotechnology industry
- Opportunity for career advancement and growth within the organization
- Collaborative work environment with cross-functional teamwork
- Involvement in the preparation and publishing of global regulatory submissions
- Chance to mentor junior staff and provide guidance on complex submissions
- Competitive benefits package and a focus on continuous improvement
What to Expect (Job Responsibilities):
- Manage the end-to-end preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD)
- Collaborate with Regulatory Affairs, CMC, Medical Writing, Quality, and other stakeholders for timely and accurate submissions
- Perform thorough quality control reviews to ensure submission-ready documents meet regulatory standards
- Lead and contribute to the development, revision, implementation, and training of departmental SOPs and standardized publishing processes
- Troubleshoot technical issues related to publishing tools and document formatting
What is Required (Qualifications):
- Bachelor’s Degree required; Advanced Degree desirable
- Minimum five (5) years of regulatory operations experience in the pharmaceutical or biotechnology industry
- Proven expertise in eCTD submissions in support of U.S., Canada, EU, and Asia-Pacific regulatory requirements
- Strong understanding of electronic publishing tools and Regulatory Information Management (RIM) systems
- Excellent written and verbal communication skills to document processes and collaborate across teams
How to Stand Out (Preferred Qualifications):
- Demonstrated experience managing multiple submission projects in parallel
- Proven experience in developing, revising, and maintaining departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- Strong understanding of the drug development process and project management experience
- In-depth knowledge of document management processes in a regulated pharmaceutical environment
- Strong software troubleshooting skills
#Pharmaceuticals #RegulatoryOperations #CareerOpportunity #eCTDSubmissions #ContinuousImprovement
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