Employer Industry: Pharmaceutical Regulatory Affairs

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Competitive salary based on experience and qualifications
- Engaging and supportive work environment
- Chance to work on critical regulatory submissions for pharmaceuticals and devices
- Involvement in the transition from legacy to electronic submissions, enhancing technical skills

What to Expect (Job Responsibilities):
- Prepare, compile, and deliver regulatory submissions in compliance with regional requirements and company standards
- Collaborate with functional departments to ensure proper formatting and handoff of submission components
- Conduct quality checks and validations of documents for FDA submission
- Troubleshoot document issues using MS Word and Adobe Acrobat
- Mentor junior staff and assist with complex tasks requiring advanced knowledge

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
- Prior experience with electronic document management systems
- Proficiency in MS Office, particularly MS Word, and Adobe Acrobat (version 5.0 or higher)
- Strong understanding of document management processes in a regulated pharmaceutical/device environment

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

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