Johnson & Johnson Pvt Ltd is hiring B. Pharma/ M. Pharma as a Sr. Executive Regulatory Affairs – Apply Now

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Johnson & Johnson Pvt Ltd is hiring B. Pharma/ M. Pharma as a Sr. Executive Regulatory Affairs – Apply Now

• 2 years ago
• Read Time: 3 minutes
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Exciting career prospects await pharmaceutical professionals as Johnson & Johnson opens its doors to candidates with a B. Pharma or M. Pharma background for the prestigious role of Regulatory Affairs Executive. This esteemed opportunity marks a pivotal moment for individuals eager to carve a niche in regulatory affairs within one of the world’s leading healthcare companies.

Job title: Sr. Executive, Regulatory Affairs

Qualification: B. Pharma/ M.Pharma

Job Function: Regulatory Affairs

Job Purpose

• Regulatory and quality compliance for the entire Johnson & Johnson Medical franchises in India
• To maintain the Life cycle management of the product registered by Johnson & Johnson
• Developed regulatory strategies along with internal stakeholders to coordinate and mitigate interdependencies of overlapping projects to successfully submit application to HA averting any business impact
• Ensures compliance with regulatory agency regulations and interpretations
  
  

Essential Duties And Responsibilities

• Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer) for India market.
• Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India market in accordance with applicable regulations and relevant guidelines.
• Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise.
• Update and live maintenance of business plan in sharepoint for assigned franchises/ licenses.
• Assist in the preparation of technical presentations/ meetings with regulator.
• 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 (Lifecycle management)
• Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/franchises.
• Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations
• Maintenance of RA database for the responsible franchises in MDRIM tool.
• Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals.
• Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system. Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure.
• Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/ other portal.
• Ensure on time archival of regulatory submission documents.
• 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.
• Other assignment identified and assigned by Supervisor/ management- time to time.
  
  

Special Requirements

• Strong knowledge of Medical Device Rule 2017 and Drugs and Cosmetics Act
• Knowledge in the international regulations of Medical Devices in US and EU
• Sound knowledge on Medical Device Quality Management System ISO 13485
• Excellent proficiency with software tools
  
  

Qualifications

Essential knowledge and skills:

• Graduate/ Post Graduate in Lifescience/ Bio Medical/ Pharmacy
• Minimum 2-6 years Industry Experience in Regulatory Affairs, preferably in medical devices. Sound understanding of MD rules and regulations in India.
• Experience of Submitting, Registering and maintaining Product registrations with MOH
• Experience in quality/ manufacturing and regulatory affairs in medical devices would be advantage
• Experience in assembling product dossiers for submission to Regulatory Authorities.
• Good technical writing and communication skills.
  
  

Core Competencies Required For This Role

• Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook
• Translate insights into innovative and viable products or solutions that create value
• Challenge the status quo; lead and adapt to change
• Engage in transparent and constructive conversations
  
  

Primary Location Asia Pacific-India-Haryana-Gurgaon Organization Johnson & Johnson Private Limited (8080) Apply Online Click Here

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