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 : Regulatory Affairs Manager
• Coordination with and provide necessary directions to Liaison manager based in Delhi with regards to various applications for the assigned therapeutic area
• Coordination with and provide necessary directions to the distributor in the assigned country
• Interactions and coordination with sales, marketing, supply chain, finance in relation to assigned responsibility.
• Ensure compliance to organizational SOPs and various compliance systems for the assigned area of responsibility.
• Responsible for regulatory intelligence activities and competitiveness assessment and monitoring activities.
• Contributes to process simplification of processes applicable for RA function to bring in clarity about the applicable SOPs within RA function.
• Provide mentorship support and supervision to RA Assistant / Executive as applicable
• Degree / Post Graduation in Pharmacy/life sciences with 8-10 years prior experience working with multinational pharmaceutical organization in Regulatory Affairs function
• Thorough understanding of CDSCO functioning and expertise in SUGAM
• Fluency in English communication, good eye for details and analytical skills
• Thorough knowledge of applicable regulations like Drugs and Cosmetics Act, Drugs and Cosmetics Rules, New Drugs and Clinical Trials Rules, Drugs Price Control Order, Drugs and Magic Remedies (Objectionable Advertisements) Act and the Rules, Narcotic Drugs and Psychotropic Substances Act & The Rules
Experience : 5+ years
Qualification : Degree / Post Graduation in Pharmacy/life sciences
Location : Maharashtra - Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th June, 2021
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