Employer Industry: Pharmaceutical Regulatory Affairs

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Work in a dynamic and innovative environment within the pharmaceutical industry
- Collaborate with cross-functional teams to enhance regulatory submission processes
- Engage in mentoring junior staff and contributing to the development of departmental standards
- Contribute to the transition from legacy to electronic submissions, shaping future practices

What to Expect (Job Responsibilities):
- Prepare, compile, quality check, and deliver regulatory submissions in compliance with regional requirements and company standards
- Collaborate with functional departments to ensure proper formatting and understanding of submission components
- Troubleshoot document issues using MS Word and Adobe Acrobat
- Ensure timely receipt and formatting of all required documents for regulatory submissions
- Participate in the development of standards and processes for efficient submission development and archival

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
- Must be highly proficient in MS Office (emphasis on 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 highly desirable
- Outstanding interpersonal and communication (written and verbal) skills

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