Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.
Post : Executive - Regulatory Affairs
Job Description
• Compilation of documents for Registration of Drugs
• Liaise with regional team for supporting documents and dossiers for product registration and for tenders
• Provide inputs of regulatory affairs and ensure HA submissions for PMS and Phase IV studies: Quarterly and six-monthly study reports for PMS studies, clinical reports stability protocols and non-clinical study reports
• Coordination with Regulatory Consultants for the effective submission of application at DCGI
• Archival of dossiers, Approvals and DCGI submission copies
• Providing support in Life Cycle management of registered products
• Managing trackers and supporting tenders by providing various documents from regulatory perspective.
Candidate Profile
• Bachelor’s degree or Master’s degree in Science / Pharma
• Minimum experience of 1 -3 years of Pharmaceutical sales with validated performance track record
Additional Information
Experience : 1-3 years
Qualification : M.Pharm, B.Pharm or M.Sc, B.Sc
Location : Maharashtra - Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th January, 2022
See All B.Pharm Alerts M.Pharm Alerts Ph.D Alerts Mumbai Alerts
See All Other Jobs in our Database
.png)
