Country Approval Specialist
Thermo Fisher Scientific
Country Approval Specialist
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
- Determine and prepare country-specific submission dossiers for DCGI & EC meeting regulatory requirements for clinical trial submissions.
- Successfully implement submission strategies to acquire regulatory and ethics committee approvals. Forecast timelines for the critical activities. Liaise with regulatory authorities and investigators to facilitate approval processes.
- Collaborate with cross-functional teams to ensure timely and accurate documentation, optimise study startup timelines.
- Obtain and review essential documents, ensure systems updation and filing.
- Monitor and ensure compliance with local and international regulations.
- Work and drive the amendments and support the ongoing submissions, notifications for the ongoing studies.
- Provide guidance and support to project teams on local regulatory and GCP requirements, timelines and strategy.
Locations
- Mumbai, Mahārāshtra, India
Salary
Estimated Salary Rangemedium confidence
50,000 - 90,000 INR / yearly
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Regulatory compliance (DCGI, EC)intermediate
- GCP requirementsintermediate
- Clinical trial submissionsintermediate
Responsibilities
- Determine and prepare country-specific submission dossiers
- Implement submission strategies for regulatory and ethics approvals
- Forecast timelines for critical activities
- Liaise with regulatory authorities and investigators
- Collaborate with cross-functional teams for documentation and study startup
- Obtain and review essential documents, update systems and filing
- Monitor compliance with local and international regulations
- Drive amendments and support ongoing submissions/notifications
- Provide guidance on regulatory and GCP requirements, timelines, and strategy
Answer 10 quick questions to check your fit for Country Approval Specialist @ Thermo Fisher Scientific.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs
Country Approval Specialist
Thermo Fisher Scientific
Country Approval Specialist
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
- Determine and prepare country-specific submission dossiers for DCGI & EC meeting regulatory requirements for clinical trial submissions.
- Successfully implement submission strategies to acquire regulatory and ethics committee approvals. Forecast timelines for the critical activities. Liaise with regulatory authorities and investigators to facilitate approval processes.
- Collaborate with cross-functional teams to ensure timely and accurate documentation, optimise study startup timelines.
- Obtain and review essential documents, ensure systems updation and filing.
- Monitor and ensure compliance with local and international regulations.
- Work and drive the amendments and support the ongoing submissions, notifications for the ongoing studies.
- Provide guidance and support to project teams on local regulatory and GCP requirements, timelines and strategy.
Locations
- Mumbai, Mahārāshtra, India
Salary
Estimated Salary Rangemedium confidence
50,000 - 90,000 INR / yearly
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Regulatory compliance (DCGI, EC)intermediate
- GCP requirementsintermediate
- Clinical trial submissionsintermediate
Responsibilities
- Determine and prepare country-specific submission dossiers
- Implement submission strategies for regulatory and ethics approvals
- Forecast timelines for critical activities
- Liaise with regulatory authorities and investigators
- Collaborate with cross-functional teams for documentation and study startup
- Obtain and review essential documents, update systems and filing
- Monitor compliance with local and international regulations
- Drive amendments and support ongoing submissions/notifications
- Provide guidance on regulatory and GCP requirements, timelines, and strategy
Answer 10 quick questions to check your fit for Country Approval Specialist @ Thermo Fisher Scientific.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs