Fresenius Medical Care North America
Sr Global Regulatory Associate (eCTD Publishing)
This job is now closed
Job Description
- Req#: R0208010
Employer Industry: Pharmaceutical and Biotechnology
Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Work in a dynamic environment focused on regulatory compliance and innovation
- Collaborate with cross-functional teams to impact global submission processes
- Involvement in continuous improvement initiatives and departmental training programs
- Chance to mentor junior staff and enhance your leadership skills
What to Expect (Job Responsibilities):
- Manage the end-to-end preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD)
- Perform thorough quality control reviews to ensure submission-ready documents meet regulatory standards
- Collaborate cross-functionally with stakeholders to ensure timely and accurate submission components
- Lead the development and implementation of departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- 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 for U.S. (FDA), Canada (Health Canada), EU (EMA, MHRA), and Asia-Pacific (PMDA, TGA, NMPA, etc.)
- Strong understanding of electronic publishing tools and Regulatory Information Management (RIM) systems
- Excellent written and verbal communication skills, with the ability to document processes clearly
How to Stand Out (Preferred Qualifications):
- Demonstrated understanding of the drug development process and project management experience
- Proven experience in developing and maintaining departmental Standard Operating Procedures (SOPs) and internal processes
- Strong software troubleshooting skills, particularly with MS Word and Adobe Acrobat
#Pharmaceutical #Biotechnology #RegulatoryOperations #CareerOpportunity #eCTDSubmissions
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