Submission Specialist
Bristol-Myers Squibb
Submission Specialist
Job Description
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. Supporting People with Disabilities 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. BA/BS degree, science / technology field preferred.
Key Responsibilities
- Track, collect, and review all components for routine submissions to Health Authorities
- Interact with responsible parties to ensure quality submission documents for routine submissions
- Troubleshoot issues found in received components and interact 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 compliance
- Update RIM system with US planned submissions and update entries with submitted submissions
- Participate in submission team meetings as applicable
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Engage in other miscellaneous regulatory operational activities as needed
Required Qualifications
- BA/BS degree in a science or technology field
- -2 years of pharmaceutical experience
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements
Preferred Qualifications
- Degree in a science or technology field
Skills Required
- Proficient in the English language both written and oral
- Ability to communicate effectively in written form with non-English speakers
- Basic presentation skills to deliver content to a variety of audiences
- Ability to execute a non-complex project, including prioritizing tasks with strong attention to detail
- Critical thinking skills for daily workload decisions, aligned with group/company objectives
- Ability to seek understanding of stakeholder needs, priorities, working processes, and activities
- Good understanding of desktop application software suites
- Practical knowledge of computer systems in an R&D environment
Benefits & Perks
- Supporting People with Disabilities
Additional Requirements
- Understands the importance of resolving issues in a timely manner
- Escalates questions and issues as they arise
- Engages relevant stakeholders to help address problems, as appropriate
- Communicates project status and updates, as appropriate, to relevant stakeholders
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
300,000 - 600,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Proficient in the English language both written and oralintermediate
- Ability to communicate effectively in written form with non-English speakersintermediate
- Basic presentation skills to deliver content to a variety of audiencesintermediate
- Ability to execute a non-complex project, including prioritizing tasks with strong attention to detailintermediate
- Critical thinking skills for daily workload decisions, aligned with group/company objectivesintermediate
- Ability to seek understanding of stakeholder needs, priorities, working processes, and activitiesintermediate
- Good understanding of desktop application software suitesintermediate
- Practical knowledge of computer systems in an R&D environmentintermediate
Required Qualifications
- BA/BS degree in a science or technology field (experience)
- -2 years of pharmaceutical experience (experience)
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements (experience)
Preferred Qualifications
- Degree in a science or technology field (experience)
Responsibilities
- Track, collect, and review all components for routine submissions to Health Authorities
- Interact with responsible parties to ensure quality submission documents for routine submissions
- Troubleshoot issues found in received components and interact 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 compliance
- Update RIM system with US planned submissions and update entries with submitted submissions
- Participate in submission team meetings as applicable
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Engage in other miscellaneous regulatory operational activities as needed
Benefits
- general: Supporting People with Disabilities
Tags & Categories
Submission Specialist
Bristol-Myers Squibb
Submission Specialist
Job Description
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. Supporting People with Disabilities 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. BA/BS degree, science / technology field preferred.
Key Responsibilities
- Track, collect, and review all components for routine submissions to Health Authorities
- Interact with responsible parties to ensure quality submission documents for routine submissions
- Troubleshoot issues found in received components and interact 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 compliance
- Update RIM system with US planned submissions and update entries with submitted submissions
- Participate in submission team meetings as applicable
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Engage in other miscellaneous regulatory operational activities as needed
Required Qualifications
- BA/BS degree in a science or technology field
- -2 years of pharmaceutical experience
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements
Preferred Qualifications
- Degree in a science or technology field
Skills Required
- Proficient in the English language both written and oral
- Ability to communicate effectively in written form with non-English speakers
- Basic presentation skills to deliver content to a variety of audiences
- Ability to execute a non-complex project, including prioritizing tasks with strong attention to detail
- Critical thinking skills for daily workload decisions, aligned with group/company objectives
- Ability to seek understanding of stakeholder needs, priorities, working processes, and activities
- Good understanding of desktop application software suites
- Practical knowledge of computer systems in an R&D environment
Benefits & Perks
- Supporting People with Disabilities
Additional Requirements
- Understands the importance of resolving issues in a timely manner
- Escalates questions and issues as they arise
- Engages relevant stakeholders to help address problems, as appropriate
- Communicates project status and updates, as appropriate, to relevant stakeholders
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
300,000 - 600,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Proficient in the English language both written and oralintermediate
- Ability to communicate effectively in written form with non-English speakersintermediate
- Basic presentation skills to deliver content to a variety of audiencesintermediate
- Ability to execute a non-complex project, including prioritizing tasks with strong attention to detailintermediate
- Critical thinking skills for daily workload decisions, aligned with group/company objectivesintermediate
- Ability to seek understanding of stakeholder needs, priorities, working processes, and activitiesintermediate
- Good understanding of desktop application software suitesintermediate
- Practical knowledge of computer systems in an R&D environmentintermediate
Required Qualifications
- BA/BS degree in a science or technology field (experience)
- -2 years of pharmaceutical experience (experience)
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements (experience)
Preferred Qualifications
- Degree in a science or technology field (experience)
Responsibilities
- Track, collect, and review all components for routine submissions to Health Authorities
- Interact with responsible parties to ensure quality submission documents for routine submissions
- Troubleshoot issues found in received components and interact 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 compliance
- Update RIM system with US planned submissions and update entries with submitted submissions
- Participate in submission team meetings as applicable
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Engage in other miscellaneous regulatory operational activities as needed
Benefits
- general: Supporting People with Disabilities
Tags & Categories