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

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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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