Regulatory Submission Expert
2 days ago
Transforming Patients' Lives with Innovative Solutions
Bristol Myers Squibb is an organization where unique and interesting work happens every day. We are a global hub focused on helping patients prevail over serious diseases by building sustainable and innovative solutions.
About the Role
The Senior Submission Specialist plays a crucial part in supporting the planning, organization, and review of routine submissions for chemistry, manufacturing and controls (CMC) and regulatory. This role involves interacting with responsible parties for quality submission documents and troubleshooting issues found in components received.
Main Responsibilities
- Tracks and collects all components for routine submissions to Health Authorities.
- Interacts with responsible parties for quality submission documents.
- Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision.
- Assists with translation document management activities.
- Distributes, tracks, and archives non-eCTD submissions globally.
- Leads contact to ensure Literature References are in the DMS correctly.
- Drafts eCTD content plans for CMC submissions.
Requirements and Qualifications
- BA/BS degree, preferably in science or technology.
- 3+ years relevant submissions experience.
Key Competencies
- Fundamental knowledge of global regulatory practices and electronic submission guidelines.
- Effective written and verbal communication skills.
- Ability to prioritize tasks and maintain attention to detail.
- Technical savvy with Microsoft Office, Outlook, eCTD viewers, and web-based applications.
Salary Estimate
We estimate the salary for this position to be around $80,000 - $110,000 per annum, based on industry standards and location considerations.
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