SR. EXECUTIVE, REGULATORY AFFAIRS

Job title.
Sr.
Executive, Regulatory Affairs Overall purpose of job.
• 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 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 • Excellent proficiency with software tools Job location.
Gurgaon, Haryana- India 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