Global Regulatory Affairs-CMC Co-Op
| Company | Inventing for Life |
|---|---|
| Location | Linden, NJ, USA |
| Salary | $19.038461538462 – $50.721153846154 |
| Type | Internship |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Internship |
Requirements
- Must be currently enrolled in a sophomore or junior level curriculum working toward a Bachelor’s degree, or pursuing a Master’s or higher degree in related sciences (engineering, biological sciences or chemistry) or regulatory affairs discipline
- Have superior analytical and technical competency as demonstrated by excellent academic record and work achievements.
- Have strong communication skills, personal character, and ethics
- Have working knowledge MS Office suite
Responsibilities
- Assist with the system transition to Regulatory Information Management Systems (RIMS) SharePoint and s: drive to Archives and Alexx
- Fulfill document requests received via GRA Request Tracking Tool (RTT) to support PMs to focus on submission writing by liaising with cross-functional stakeholders
- Renewals & Geo-Expansions– GMP licenses, certificates, reports, etc.
- Backlog reduction; Metrics support
- Health Authority List of Questions (LoQs) trending
- Collect and organize LoQs
- Analyze and trend; develop metrics
- Regulatory Affairs Detailed Application Verification (DAV)- verification, maintenance
- Assist with other activities, e.g. new colleague onboarding/training scheduling
- Optimize existing processes/ analyze for improvement opportunities
Preferred Qualifications
- Knowledge of Six Sigma principles
- Have leadership accomplishments achieved through direct leadership roles or leading by influence.
- Have demonstrated delivery results in a multi-functional, multi-disciplinary environment.
- Candidates should have a minimum GPA of 3.0