Submission specialist(Bristol myers squibb)

Roles and Responsibilities

Responsibilities

• Tracks, collects, and reviews all components for routine submissions to Health Authorities.

• Interacts with responsible parties for quality submission documents for routine submissions.

• Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision.

• Prepare Cover Letter, FDA Forms and submission content plan for routine submissions.

• Perform submission verification on published submissions to confirm eCTD compliant

• Update RIM system with US planned submissions and update entries with submitted submissions.

• Participates in submission team meeting as applicable Coordinate non-eCTD submissions with International Regulatory Team lead.

• Other miscellaneous regulatory operational activities as needed.

Qualification

• 0-2 years pharmaceutical experience

• Foundational knowledge of global regulatory practices, submission guidelines and requirements.

• Understands the importance of resolving issues in a timely manner.

• Escalates questions and issues as they arise.

• Engages relevant stakeholders to help address the problem, as appropriate.

• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.

• Demonstrates basic presentation skills needed to deliver content to a variety of audiences.

• Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail.

• Communicates project status and updates, as appropriate, to relevant stakeholders.

• Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives

• Seeks to understand stakeholder needs, priorities, working processes, and activities.

• Good understanding of desktop application software suites.

• Practical knowledge of computer systems in an R&D environment.

Degree Requirement

• BA/BS degree, science / technology field preferred.