Employer Industry: Pharmaceutical Regulatory Affairs

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Engaging work environment focused on regulatory compliance and submission processes
- Chance to work on innovative projects in the pharmaceutical and device sectors
- Collaborate with diverse teams to ensure adherence to regulatory standards
- Contribute to the development of electronic submission processes

What to Expect (Job Responsibilities):
- Prepare, compile, and deliver regulatory submissions in both paper and electronic formats
- Collaborate with functional departments to ensure submission components meet requirements
- Troubleshoot document issues in MS Word and Adobe Acrobat
- Compile, publish, and validate documents for FDA submission
- Mentor junior staff and assist with complex tasks as needed

What is Required (Qualifications):
- Bachelor’s Degree required; Advanced Degree desirable
- 5 – 8 years of related experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience
- Prior experience with electronic document management systems is required
- Strong understanding of document management processes in a regulated pharmaceutical/device environment
- Highly proficient in MS Office, particularly MS Word, and Adobe Acrobat (version 5.0 or higher)

How to Stand Out (Preferred Qualifications):
- Knowledge of EDM, RIM, and electronic publishing software
- Experience with electronic submissions, specifically eCTD or eCopy
- Demonstrated understanding of the drug development process and project management experience
- Strong software troubleshooting skills
- Outstanding interpersonal and communication skills

#Pharmaceuticals #RegulatoryAffairs #CareerOpportunity #DocumentManagement #FDACompliance

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