Opening in Regulatory affairs domain for Life science / Pharma candidates @ Johnson & Johnson
In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices & Diagnostics, which are independently managed and report into their respective Global business segments.J&J Medical India (JJMI) is the market leader in the Medical Company Devices & Diagnostics Industry in India. It is in the business of caring and providing solutions to doctors, patients and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Vision Care, Orthopaedics, Infection Prevention, Wound Management, Women’s health, Minimally invasive surgery, Circulatory disease management, and Blood glucose monitoring and insulin delivery.
Job Title : Executive- Regulatory Affairs
Eligibility : M.sc Life science / Pharma
Experience : 5-6 years
Job Description :
Compilation, review and submissions of Regulatory filings for India
Ensures compliance with regulatory agency regulations and interpretations Gathers and assembles information, prepares documents for New Product Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines
Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations
Provides regulatory advice to project teams
Organizes and maintains reports of schedules for new Medical Device applications and Renewal Applications.
Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines
Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner
Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware
Click here to apply
In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices & Diagnostics, which are independently managed and report into their respective Global business segments.J&J Medical India (JJMI) is the market leader in the Medical Company Devices & Diagnostics Industry in India. It is in the business of caring and providing solutions to doctors, patients and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Vision Care, Orthopaedics, Infection Prevention, Wound Management, Women’s health, Minimally invasive surgery, Circulatory disease management, and Blood glucose monitoring and insulin delivery.
Job Title : Executive- Regulatory Affairs
Eligibility : M.sc Life science / Pharma
Experience : 5-6 years
Job Description :
Compilation, review and submissions of Regulatory filings for India
Ensures compliance with regulatory agency regulations and interpretations Gathers and assembles information, prepares documents for New Product Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines
Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations
Provides regulatory advice to project teams
Organizes and maintains reports of schedules for new Medical Device applications and Renewal Applications.
Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines
Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner
Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware
Click here to apply
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