Senior Specialist, CMC Submission Management
Bristol-Myers Squibb
Senior Specialist, CMC Submission Management
Job Description
Tracks, collects, and reviews all components for submission to Health Authorities. Perform submission publishing activities 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. 5+ years relevant experience in regulatory submissions. Foundational knowledge of global regulatory practices, submission guidelines and requirements. Proficient working knowledge of common desktop applications (e.g., Microsoft Office Suite, Adobe Acrobat, SharePoint). Hands-on experience in submission publishing activities using DocuBridge, Lorenz and other relevant software (e.g., Veeva) 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. 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. Proposes alternative solutions for submission-related and/or project situations. Seeks to understand stakeholder needs, priorities, working processes, and activities. Understands and embraces the use of specific regulatory systems and associated tools based on area of expertise or job function. Has intermediate-level working knowledge of common desktop software (eg, Microsoft Office Suite, Adobe Acrobat, and SharePoint). BA/BS degree, science / technology field preferred.
About the Role/Company
- Position is within RISM (Regulatory Information and Submission Management)
Key Responsibilities
- Track, collect, and review all components for submission to Health Authorities
- Perform submission publishing activities
- Interact with responsible parties to ensure quality submission documents
- Facilitate submission team meetings and provide team support
- Participate in focused projects related to 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
- Communicate project status and updates to relevant stakeholders
- Apply critical thinking skills to daily workload decisions in alignment with group/company objectives
- Propose alternative solutions for submission-related and/or project situations
- Seek to understand stakeholder needs, priorities, working processes, and activities
- Understand and embrace the use of specific regulatory systems and associated tools based on area of expertise or job function
Required Qualifications
- + years relevant experience in regulatory submissions
- BA/BS degree, science / technology field preferred
Skills Required
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements
- Proficient working knowledge of common desktop applications (e.g., Microsoft Office Suite, Adobe Acrobat, SharePoint)
- Hands-on experience in submission publishing activities using DocuBridge, Lorenz, and other relevant software (e.g., Veeva)
- Proficient in the English language both written and oral
- 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
- Intermediate-level working knowledge of common desktop software (e.g., Microsoft Office Suite, Adobe Acrobat, and SharePoint)
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Foundational knowledge of global regulatory practices, submission guidelines, and requirementsintermediate
- Proficient working knowledge of common desktop applications (e.g., Microsoft Office Suite, Adobe Acrobat, SharePoint)intermediate
- Hands-on experience in submission publishing activities using DocuBridge, Lorenz, and other relevant software (e.g., Veeva)intermediate
- Proficient in the English language both written and oralintermediate
- Able to communicate effectively in written form with non-English speakersintermediate
- Demonstrates basic presentation skills needed to deliver content to a variety of audiencesintermediate
- Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detailintermediate
- Intermediate-level working knowledge of common desktop software (e.g., Microsoft Office Suite, Adobe Acrobat, and SharePoint)intermediate
Required Qualifications
- + years relevant experience in regulatory submissions (experience)
- BA/BS degree, science / technology field preferred (experience)
Responsibilities
- Track, collect, and review all components for submission to Health Authorities
- Perform submission publishing activities
- Interact with responsible parties to ensure quality submission documents
- Facilitate submission team meetings and provide team support
- Participate in focused projects related to 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
- Communicate project status and updates to relevant stakeholders
- Apply critical thinking skills to daily workload decisions in alignment with group/company objectives
- Propose alternative solutions for submission-related and/or project situations
- Seek to understand stakeholder needs, priorities, working processes, and activities
- Understand and embrace the use of specific regulatory systems and associated tools based on area of expertise or job function
Tags & Categories
Senior Specialist, CMC Submission Management
Bristol-Myers Squibb
Senior Specialist, CMC Submission Management
Job Description
Tracks, collects, and reviews all components for submission to Health Authorities. Perform submission publishing activities 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. 5+ years relevant experience in regulatory submissions. Foundational knowledge of global regulatory practices, submission guidelines and requirements. Proficient working knowledge of common desktop applications (e.g., Microsoft Office Suite, Adobe Acrobat, SharePoint). Hands-on experience in submission publishing activities using DocuBridge, Lorenz and other relevant software (e.g., Veeva) 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. 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. Proposes alternative solutions for submission-related and/or project situations. Seeks to understand stakeholder needs, priorities, working processes, and activities. Understands and embraces the use of specific regulatory systems and associated tools based on area of expertise or job function. Has intermediate-level working knowledge of common desktop software (eg, Microsoft Office Suite, Adobe Acrobat, and SharePoint). BA/BS degree, science / technology field preferred.
About the Role/Company
- Position is within RISM (Regulatory Information and Submission Management)
Key Responsibilities
- Track, collect, and review all components for submission to Health Authorities
- Perform submission publishing activities
- Interact with responsible parties to ensure quality submission documents
- Facilitate submission team meetings and provide team support
- Participate in focused projects related to 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
- Communicate project status and updates to relevant stakeholders
- Apply critical thinking skills to daily workload decisions in alignment with group/company objectives
- Propose alternative solutions for submission-related and/or project situations
- Seek to understand stakeholder needs, priorities, working processes, and activities
- Understand and embrace the use of specific regulatory systems and associated tools based on area of expertise or job function
Required Qualifications
- + years relevant experience in regulatory submissions
- BA/BS degree, science / technology field preferred
Skills Required
- Foundational knowledge of global regulatory practices, submission guidelines, and requirements
- Proficient working knowledge of common desktop applications (e.g., Microsoft Office Suite, Adobe Acrobat, SharePoint)
- Hands-on experience in submission publishing activities using DocuBridge, Lorenz, and other relevant software (e.g., Veeva)
- Proficient in the English language both written and oral
- 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
- Intermediate-level working knowledge of common desktop software (e.g., Microsoft Office Suite, Adobe Acrobat, and SharePoint)
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Foundational knowledge of global regulatory practices, submission guidelines, and requirementsintermediate
- Proficient working knowledge of common desktop applications (e.g., Microsoft Office Suite, Adobe Acrobat, SharePoint)intermediate
- Hands-on experience in submission publishing activities using DocuBridge, Lorenz, and other relevant software (e.g., Veeva)intermediate
- Proficient in the English language both written and oralintermediate
- Able to communicate effectively in written form with non-English speakersintermediate
- Demonstrates basic presentation skills needed to deliver content to a variety of audiencesintermediate
- Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detailintermediate
- Intermediate-level working knowledge of common desktop software (e.g., Microsoft Office Suite, Adobe Acrobat, and SharePoint)intermediate
Required Qualifications
- + years relevant experience in regulatory submissions (experience)
- BA/BS degree, science / technology field preferred (experience)
Responsibilities
- Track, collect, and review all components for submission to Health Authorities
- Perform submission publishing activities
- Interact with responsible parties to ensure quality submission documents
- Facilitate submission team meetings and provide team support
- Participate in focused projects related to 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
- Communicate project status and updates to relevant stakeholders
- Apply critical thinking skills to daily workload decisions in alignment with group/company objectives
- Propose alternative solutions for submission-related and/or project situations
- Seek to understand stakeholder needs, priorities, working processes, and activities
- Understand and embrace the use of specific regulatory systems and associated tools based on area of expertise or job function
Tags & Categories