Sr. Executive, Regulatory Affairs - Gurugram, India - Johnson & Johnson

Description

• 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

• 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.

• 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