Johnson & Johnson Pvt Ltd Mumbai Job Opening For Regulatory Affairs

Johnson & Johnson Pvt Ltd Mumbai  Job Opening For Regulatory Affairs 

Job Description

REGULATORY AFFAIRS MANAGER (INFECTIOUS DISEASES, VACCINES, AND METABOLICS)

Location: Mumbai, India

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas.

Janssen India is looking for a Regulatory Affairs Manager for IDV and Metabolics, reporting to the Director of Regulatory Affairs. In this role you will mainly be responsible for end to end regulatory affairs support to designated therapeutic area of IDV & Metabolics along with management of regulatory affairs activities for Bangladesh across all the therapeutic areas. 

Other responsiblities include:

• 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

Qualifications

To be successful for the role, you will have the following:

• 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

 

Are you ready to impact the world?

Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Primary Location
India-Maharashtra-Greater Mumbai-

Organization
Johnson & Johnson Private Limited (8080)

Job Function
Regulatory Affairs

Requisition ID
2105918260W

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