Sr. Executive, Regulatory Affairs

3 weeks ago

gurugram, India Johnson and Johnson Full time
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 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 Job location: Gurgaon, Haryana- India 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

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