Employer Industry: Pharmaceutical Regulatory Affairs

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Work in a dynamic environment focused on regulatory compliance and submissions
- Collaborate with cross-functional teams to enhance regulatory processes
- Contribute to the development of new pharmaceutical products
- Supportive work culture that values mentorship and employee development

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 handling of submission components
- Troubleshoot document issues in MS Word and Adobe Acrobat
- Participate in the development of standards and processes for efficient submission management
- 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
- 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 (emphasis on MS Word) and Adobe Acrobat (version 5.0 or higher)

How to Stand Out (Preferred Qualifications):
- Knowledge of electronic document management (EDM), regulatory information management (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

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