Senior Specialist, Submission Management
Bristol-Myers Squibb
Senior Specialist, Submission Management
Job Description
The Senior Specialist manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities. Tracks, collects, and reviews all components for submission to Health Authorities. Interacts with responsible parties for quality submission documents for submissions. Facilitate submission team meetings with team support. May participate in focused projects related to their scope of work. Prepare Cover Letter, FDA Forms and submission content plan for Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission). Attend Submission Team and kick off meetings, represent RISM and drive submission publishing timelines. Coordinate Initial IND Kick off meeting submission. Coordinate IND, NDA, BLA and Orphan Drug Annual Reports. Develop/Update job aid documents for departmental process. Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist). Coordinate non-eCTD submissions with International Regulatory Team lead. Supporting People with Disabilities 3+ years relevant submissions experience Foundational knowledge of global regulatory practices, submission guidelines and requirements. Assists in the implementation of short- and long-term goals within own work group within RISM. Come prepared with a solution to questions and issues as they arise. Engages relevant stakeholders to help address the problem. BA/BS degree, science / technology field preferred.
About the Role/Company
- The company supports people with disabilities
- The department is RISM (Regulatory Information and Submission Management)
Key Responsibilities
- Manage and coordinate the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities
- Track, collect, and review all components for submission to Health Authorities
- Interact with responsible parties to ensure quality submission documents
- Facilitate submission team meetings with team support
- Participate in focused projects related to their scope of work
- Prepare Cover Letter, FDA Forms, and submission content plan for Investigational and Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission)
- Attend Submission Team and kick off meetings, represent RISM, and drive submission publishing timelines
- Coordinate Initial IND Kick off meeting submission
- Coordinate IND, NDA, BLA, and Orphan Drug Annual Reports
- Develop and update job aid documents for departmental process
- Build and manage CARA/PRISM Structures for Global CMC Submissions
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Assist in the implementation of short- and long-term goals within own work group within RISM
- Come prepared with solutions to questions and issues as they arise
- Engage relevant stakeholders to help address problems
Required Qualifications
- BA/BS degree in a science or technology field
- + years of relevant submissions experience
Preferred Qualifications
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements
Skills Required
- Ability to manage and coordinate submission processes
- Strong organizational and tracking skills
- Effective communication and interaction with responsible parties
- Ability to facilitate meetings and drive timelines
- Proficiency in preparing regulatory documents and forms
- Capability to develop and update job aids
- Knowledge in building and managing CARA/PRISM Structures
- Problem-solving skills and ability to engage stakeholders
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
1,500,000 - 2,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to manage and coordinate submission processesintermediate
- Strong organizational and tracking skillsintermediate
- Effective communication and interaction with responsible partiesintermediate
- Ability to facilitate meetings and drive timelinesintermediate
- Proficiency in preparing regulatory documents and formsintermediate
- Capability to develop and update job aidsintermediate
- Knowledge in building and managing CARA/PRISM Structuresintermediate
- Problem-solving skills and ability to engage stakeholdersintermediate
Required Qualifications
- BA/BS degree in a science or technology field (experience)
- + years of relevant submissions experience (experience)
Preferred Qualifications
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements (experience)
Responsibilities
- Manage and coordinate the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities
- Track, collect, and review all components for submission to Health Authorities
- Interact with responsible parties to ensure quality submission documents
- Facilitate submission team meetings with team support
- Participate in focused projects related to their scope of work
- Prepare Cover Letter, FDA Forms, and submission content plan for Investigational and Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission)
- Attend Submission Team and kick off meetings, represent RISM, and drive submission publishing timelines
- Coordinate Initial IND Kick off meeting submission
- Coordinate IND, NDA, BLA, and Orphan Drug Annual Reports
- Develop and update job aid documents for departmental process
- Build and manage CARA/PRISM Structures for Global CMC Submissions
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Assist in the implementation of short- and long-term goals within own work group within RISM
- Come prepared with solutions to questions and issues as they arise
- Engage relevant stakeholders to help address problems
Tags & Categories
Senior Specialist, Submission Management
Bristol-Myers Squibb
Senior Specialist, Submission Management
Job Description
The Senior Specialist manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities. Tracks, collects, and reviews all components for submission to Health Authorities. Interacts with responsible parties for quality submission documents for submissions. Facilitate submission team meetings with team support. May participate in focused projects related to their scope of work. Prepare Cover Letter, FDA Forms and submission content plan for Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission). Attend Submission Team and kick off meetings, represent RISM and drive submission publishing timelines. Coordinate Initial IND Kick off meeting submission. Coordinate IND, NDA, BLA and Orphan Drug Annual Reports. Develop/Update job aid documents for departmental process. Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist). Coordinate non-eCTD submissions with International Regulatory Team lead. Supporting People with Disabilities 3+ years relevant submissions experience Foundational knowledge of global regulatory practices, submission guidelines and requirements. Assists in the implementation of short- and long-term goals within own work group within RISM. Come prepared with a solution to questions and issues as they arise. Engages relevant stakeholders to help address the problem. BA/BS degree, science / technology field preferred.
About the Role/Company
- The company supports people with disabilities
- The department is RISM (Regulatory Information and Submission Management)
Key Responsibilities
- Manage and coordinate the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities
- Track, collect, and review all components for submission to Health Authorities
- Interact with responsible parties to ensure quality submission documents
- Facilitate submission team meetings with team support
- Participate in focused projects related to their scope of work
- Prepare Cover Letter, FDA Forms, and submission content plan for Investigational and Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission)
- Attend Submission Team and kick off meetings, represent RISM, and drive submission publishing timelines
- Coordinate Initial IND Kick off meeting submission
- Coordinate IND, NDA, BLA, and Orphan Drug Annual Reports
- Develop and update job aid documents for departmental process
- Build and manage CARA/PRISM Structures for Global CMC Submissions
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Assist in the implementation of short- and long-term goals within own work group within RISM
- Come prepared with solutions to questions and issues as they arise
- Engage relevant stakeholders to help address problems
Required Qualifications
- BA/BS degree in a science or technology field
- + years of relevant submissions experience
Preferred Qualifications
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements
Skills Required
- Ability to manage and coordinate submission processes
- Strong organizational and tracking skills
- Effective communication and interaction with responsible parties
- Ability to facilitate meetings and drive timelines
- Proficiency in preparing regulatory documents and forms
- Capability to develop and update job aids
- Knowledge in building and managing CARA/PRISM Structures
- Problem-solving skills and ability to engage stakeholders
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
1,500,000 - 2,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to manage and coordinate submission processesintermediate
- Strong organizational and tracking skillsintermediate
- Effective communication and interaction with responsible partiesintermediate
- Ability to facilitate meetings and drive timelinesintermediate
- Proficiency in preparing regulatory documents and formsintermediate
- Capability to develop and update job aidsintermediate
- Knowledge in building and managing CARA/PRISM Structuresintermediate
- Problem-solving skills and ability to engage stakeholdersintermediate
Required Qualifications
- BA/BS degree in a science or technology field (experience)
- + years of relevant submissions experience (experience)
Preferred Qualifications
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements (experience)
Responsibilities
- Manage and coordinate the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities
- Track, collect, and review all components for submission to Health Authorities
- Interact with responsible parties to ensure quality submission documents
- Facilitate submission team meetings with team support
- Participate in focused projects related to their scope of work
- Prepare Cover Letter, FDA Forms, and submission content plan for Investigational and Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission)
- Attend Submission Team and kick off meetings, represent RISM, and drive submission publishing timelines
- Coordinate Initial IND Kick off meeting submission
- Coordinate IND, NDA, BLA, and Orphan Drug Annual Reports
- Develop and update job aid documents for departmental process
- Build and manage CARA/PRISM Structures for Global CMC Submissions
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Assist in the implementation of short- and long-term goals within own work group within RISM
- Come prepared with solutions to questions and issues as they arise
- Engage relevant stakeholders to help address problems
Tags & Categories