Employer Industry: Pharmaceutical Regulatory Affairs

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Collaborative work environment with a focus on compliance and quality
- Chance to contribute to the preparation of submissions for new and existing pharmaceuticals and devices
- Engaging work that involves troubleshooting and mentoring junior staff
- Involvement in the transition to electronic submissions and new technologies

What to Expect (Job Responsibilities):
- Prepare, compile, and deliver regulatory submissions in accordance with regional requirements and company standards
- Collaborate with functional departments to ensure proper understanding and handoff of submission components
- Conduct analyses of key regulatory guidance documents and interpret electronic submission regulations
- Troubleshoot document issues in MS Word and Adobe Acrobat
- Mentor junior staff and assist with complex tasks requiring advanced understanding of functions

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 of experience; or a PhD without experience; or equivalent directly related work experience
- Prior experience with electronic document management systems 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 preferred
- Experience with electronic submissions, specifically eCTD or eCopy
- Demonstrated understanding of the drug development process and project management experience
- Strong software troubleshooting skills

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